Clinical Research Remote Jobs in Pennsylvania (US)
This page tracks remote clinical research openings that are location-eligible for Pennsylvania.
This page tracks remote clinical research openings that are location-eligible for Pennsylvania.
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Title: Cariology Clinical Research Associate Job Id: 169104 Job Category: Job Location: Remote Security Clearance: No Clearance Business Unit: Piper Companies Division: Piper Enterprise Solutions Job Description: Piper Companies is seeking a Cardiology Clinical Research Associate to support a growing clinical research program within the cardiovascular and medical device/pharmaceutical industry. The Cardiology Clinical Research Associate will be responsible for monitoring clinical trials, ensuring data integrity, and supporting investigative sites in compliance with regulatory standards and study protocols. Responsibilities of the Cardiology Clinical Research Associate: - Monitor cardiology clinical trials at investigative sites to ensure adherence to protocols, GCP guidelines, and regulatory requirements. - Conduct site initiation, routine monitoring, and close-out visits. - Review source documents and case report forms (CRFs) for accuracy, completeness, and consistency. - Identify, document, and resolve discrepancies in clinical data. - Collaborate with investigators, study coordinators, and sponsors to ensure successful study execution. - Maintain detailed documentation of site activities and monitoring reports. - Ensure all adverse events and safety data are reported appropriately. Requirements of the Cardiology Clinical Research Associate: - Bachelor's degree in Life Sciences, Nursing, or a related field. - 2+ years of clinical research monitoring experience, preferably in cardiology trials. - Strong knowledge of ICH-GCP guidelines and FDA regulations. - Experience with EDC systems and clinical trial management tools. - Excellent organizational, communication, and problem-solving skills. - Ability to travel as required for site visits. Compensation for the Cardiology Clinical Research Associate: - $100,000 - $130,000 base salary - Full Comprehensive Benefits: Health, Vision, Dental, PTO, Paid Holiday and Sick Leave if Required by Law. Keywords: cardiology clinical research associate, CRA, clinical trials, cardiology studies, GCP, FDA regulations, monitoring visits, site management, EDC systems, data integrity, clinical research, pharmaceutical, medical device, cardiovascular trials
Actalent provides scaled solutions and service capabilities that drive results and value to help customers achieve more. The company promotes consultant engagem
Job Title: Clinical Research Nurse III Location: Philadelphia United States Job Description: Job Description This Clinical Research Nurse III role combines advanced clinical nursing practice with comprehensive coordination of oncology clinical trials. The position focuses on patient-facing care, subject recruitment and enrollment, consistent study implementation, meticulous data management, and strict adherence to regulatory and reporting requirements. The nurse supports cutting-edge research in a collaborative environment, working closely with experienced physicians and a multidisciplinary team while contributing to innovative therapies and improved patient outcomes. Responsibilities - Perform core clinical nursing duties in support of oncology clinical research studies, ensuring safe, compassionate, and evidence-based patient care. - Manage subject recruitment, including identifying potential participants, conducting screening procedures, and assessing eligibility according to study protocols. - Obtain informed consent from prospective participants, clearly explaining study objectives, procedures, risks, and benefits, and ensuring understanding before enrollment. - Support and oversee participant enrollment into clinical trials, coordinating all required baseline and follow-up assessments in accordance with protocol timelines. - Collect and document clinical information and research data from study participants accurately and consistently, using established data collection tools and systems. - Conduct detailed chart reviews to verify clinical information, confirm eligibility, and ensure data completeness and accuracy. - Monitor participants for adverse events, document findings thoroughly, and perform adverse event reporting in accordance with Good Clinical Practice (GCP), institutional policies, and regulatory requirements. - Provide patient education about research studies, including visit schedules, procedures, potential side effects, and adherence requirements, reinforcing information throughout the trial. - Coordinate day-to-day study operations to ensure consistent implementation of study protocols, including scheduling visits, tests, and procedures. - Maintain data integrity by entering, updating, and verifying information in electronic systems, including Epic and other research databases, and resolving discrepancies promptly. - Ensure compliance with regulatory requirements and reporting obligations, including adherence to GCP guidelines and institutional and sponsor policies. - Interact with consortium members and external partners, fostering effective communication and collaboration across participating institutions. - Organize and coordinate meetings with consortium and study team members, including scheduling, preparing agendas, and ensuring appropriate participation. - Track and record study progress, including enrollment metrics, participant status, and key milestones, and communicate updates to stakeholders. - Schedule study-related meetings, record detailed minutes, and distribute documentation to relevant parties to ensure clear communication and follow-up on action items. - Collaborate closely with the genitourinary (GU) research team, supporting their portfolio of studies and contributing to team-based problem-solving and process improvement. - Assist with or provide leadership in aspects of study management as needed, drawing on prior management experience to support junior staff and streamline workflows. - Contribute to a culture of continuous learning and professional development by engaging in training, staying current on research protocols, and sharing best practices with colleagues. Essential Skills - Active Registered Nurse (RN) license in the state of Pennsylvania (PA RN License). - Nursing Diploma or Associate's Degree in Nursing, with the ability to practice as a registered nurse. - Minimum of 2 years of overall professional experience as a registered nurse. - Minimum of 1 year of RN clinical experience providing direct patient care. - Minimum of 1 year of clinical research experience, preferably in a research center or similar setting. - Demonstrated experience in clinical research coordination, including patient recruitment, screening, and enrollment into clinical trials. - Proficiency in collecting and documenting clinical information and research data from study participants with high accuracy. - Experience conducting chart reviews to validate eligibility criteria and ensure data completeness. - Competence in adverse event identification, documentation, and reporting in accordance with regulatory and institutional requirements. - Working knowledge of oncology clinical care and oncology research workflows. - Familiarity with Good Clinical Practice (GCP) guidelines and their application in clinical research. - Ability to provide clear, empathetic patient education about research studies, including informed consent processes. - Proficiency with Epic or similar electronic medical record systems for clinical documentation and data retrieval. - Strong organizational and time-management skills, with the ability to manage multiple studies, tasks, and timelines concurrently. - Effective verbal and written communication skills to interact with patients, study teams, and consortium members. - Attention to detail and commitment to maintaining data integrity and regulatory compliance. Additional Skills & Qualifications - Bachelor of Science in Nursing (BSN) preferred. - Some prior management or supervisory experience preferred, particularly in a clinical or research environment. - Experience working within pharmaceutical-sponsored trials or industry-partnered research is beneficial. - Background in oncology research, especially in genitourinary (GU) oncology, is advantageous. - Experience working in a research center environment, including collaboration with multidisciplinary teams. - Strong interpersonal skills and the ability to build rapport with patients, families, and colleagues. - Demonstrated ability to participate in or facilitate meetings, including preparing agendas and recording minutes. - Interest in professional growth and ongoing development within clinical research and nursing practice. Work Environment This role operates in a mixed office and hospital-based environment, providing exposure to both direct patient care settings and administrative research functions. The nurse works closely with physicians and a multidisciplinary research team on cutting-edge clinical trials, particularly within oncology and genitourinary (GU) research. Daily work involves the use of Epic electronic medical records, research databases, and standard clinical and office equipment. After approximately 60 days of training, the position may offer the flexibility to work from home one to two days per week, depending on study needs and operational requirements, with the understanding that remote work frequency may fluctuate. The culture emphasizes professional growth, with opportunities for advancement, tuition reimbursement upon conversion, and access to low-cost health benefits. The environment values collaboration, continuous learning, and participation in innovative research that advances patient care. Job Type & Location This is a Contract to Hire position based out of Philadelphia, PA. Pay and Benefits The pay range for this position is $35.00 - $45.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Philadelphia,PA. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.
Headquartered in Kenilworth, New Jersey, Merck is a global pharmaceuticals company offering products that include biologic therapies, vaccines, prescription med
Role Description CANDIDATE MUST RESIDE IN ONE OF THE FOLLOWING LOCATIONS AND BE FLUENT IN SPANISH: South Florida - Ft. Lauderdale, Miami, Boca Raton, Key Largo. The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA-Manager, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company policies and procedures, quality standards, and adverse event reporting requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems. Responsibilities include, but are not limited to: - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. - Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. - Gains an in-depth understanding of the study protocol and related procedures. - Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready. - Participates & provides inputs on site selection and validation activities. - Performs remote and on-site monitoring & oversight activities using various tools to ensure: - Data generated at site are complete, accurate and unbiased. - Subjects’ right, safety and well-being are protected. - Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. - Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out. - Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. - Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA-Manager, CRM, TA Head and CRD as needed. - Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites. - Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. - Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required. - Supports and/or leads audit/inspection activities as needed. - Performs co-monitoring visits where appropriate. - Following the country strategy defined by CRD and/or CRA-Manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities. Extent of Travel: - Ability to travel domestically and internationally approximately 65%-75% of working time. - Expected travelling 2-3 days/week. - Current driver’s license required. Qualifications - Fluent in Spanish and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively. - Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines. - Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. - Hands-on knowledge of Good Documentation Practices. - Proven Skills in Site Management including management of site performance and patient recruitment. - Demonstrated high level of monitoring skill with independent professional judgment. - Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices. - Ability to understand and analyze data/metrics and act appropriately. - Capable of managing complex issues, works in a solution-oriented manner. - Performs root cause analysis and implements preventative and corrective action. Requirements - Effective time management, organizational and interpersonal skills, conflict management, problem solving skills. - Demonstrated high level of monitoring skill with independent professional judgement. - Able to work highly independently across multiple protocols, sites and therapy areas. - High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment. - Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships. - Demonstrates commitment to Customer focus. - Works with high quality and compliance mind-set. - Positive mindset, growth mindset, capable of working independently and being self-driven. - Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices. Experience and Educational Requirements - Associate's degree, certificate or equivalent in a scientific / healthcare discipline together with at least 5 years of relevant experience in the healthcare field, including at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO. - Or Bachelor's degree (or above) together with at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO. Required Skills - Adaptability - Adverse Event Reporting System - Clinical Research Methods - Clinical Site Management - Clinical Study Management - Clinical Trial Planning - Clinical Trials - Clinical Trials Monitoring - Data Analysis - Data Reporting - Early Clinical Development - Good Clinical Data Management Practice (GCDMP) - Pharmacovigilance - Preventive Action - Protocol Adherence - Regulatory Affairs Compliance - Regulatory Compliance - Site Management Preferred Skills - Current Employees apply HERE - Current Contingent Workers apply HERE Benefits - Comprehensive package of benefits including medical, dental, vision healthcare and other insurance benefits (for employee and family). - Retirement benefits, including 401(k). - Paid holidays, vacation, and compassionate and sick days.
Headquartered in Kenilworth, New Jersey, Merck is a global pharmaceuticals company offering products that include biologic therapies, vaccines, prescription med
Role Description The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA-Manager, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company's policies and procedures, quality standards, and adverse event reporting requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and Systems. - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. - Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. - Gains an in-depth understanding of the study protocol and related procedures. - Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready. - Participates & provides inputs on site selection and validation activities. - Performs remote and on-site monitoring & oversight activities using various tools to ensure: - Data generated at site are complete, accurate and unbiased. - Subjects’ right, safety and well-being are protected. - Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. - Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out. - Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. - Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA-Manager, CRM, TA Head and CRD as needed. - Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites. - Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. - Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required. - Supports and/or leads audit/inspection activities as needed. - Performs co-monitoring visits where appropriate. - Following the country strategy defined by CRD and/or CRA-Manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities. Qualifications - Associate's degree, certificate or equivalent in a scientific / healthcare discipline together with at least 5 years of relevant experience in the healthcare field, including at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO. - Or Bachelor’s degree (or above) together with at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO. Requirements - Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively. - Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines. - Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. - Hands on knowledge of Good Documentation Practices. - Proven Skills in Site Management including management of site performance and patient recruitment. - Demonstrated high level of monitoring skill with independent professional judgment. - Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices. - Ability to understand and analyze data/metrics and act appropriately. - Capable of managing complex issues, works in a solution-oriented manner. - Performs root cause analysis and implements preventative and corrective action. Benefits - Comprehensive package of benefits including medical, dental, vision healthcare and other insurance benefits (for employee and family). - Retirement benefits, including 401(k). - Paid holidays, vacation, and compassionate and sick days.
Headquartered in Kenilworth, New Jersey, Merck is a global pharmaceuticals company offering products that include biologic therapies, vaccines, prescription med
Role Description The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA-Manager, the person ensures compliance of study conduct with ICH/GCP and country regulations, our Company's policies and procedures, quality standards, and adverse event reporting requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems. - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. - Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. - Gains an in-depth understanding of the study protocol and related procedures. - Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready. - Participates & provides inputs on site selection and validation activities. - Performs remote and on-site monitoring & oversight activities using various tools to ensure: - Data generated at site are complete, accurate and unbiased. - Subjects’ rights, safety and well-being are protected. - Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. - Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out. - Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. - Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA-Manager, CRM, TA Head and CRD as needed. - Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites. - Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. - Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required. - Supports and/or leads audit/inspection activities as needed. - Performs co-monitoring visits where appropriate. - Following the country strategy defined by CRD and/or CRA-Manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities. Qualifications - Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively. - Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines. - Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. - Hands-on knowledge of Good Documentation Practices. - Proven Skills in Site Management including management of site performance and patient recruitment. - Demonstrated high level of monitoring skill with independent professional judgment. - Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices. - Ability to understand and analyze data/metrics and act appropriately. - Capable of managing complex issues, works in a solution-oriented manner. - Performs root cause analysis and implements preventative and corrective action. Requirements - Effective time management, organizational and interpersonal skills, conflict management, problem-solving skills. - Able to work highly independently across multiple protocols, sites and therapy areas. - High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment. - Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships. - Demonstrates commitment to Customer focus. - Works with high quality and compliance mind-set. - Positive mindset, growth mindset, capable of working independently and being self-driven. - Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices. Experience and Educational Requirements - Associate's degree, certificate or equivalent in a scientific / healthcare discipline together with at least 5 years of relevant experience in the healthcare field, including at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO. - Or Bachelor’s degree (or above) together with at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO. Benefits - Comprehensive package of benefits including medical, dental, vision healthcare and other insurance benefits (for employee and family). - Retirement benefits, including 401(k). - Paid holidays, vacation, and compassionate and sick days.
Headquartered in Kenilworth, New Jersey, Merck is a global pharmaceuticals company offering products that include biologic therapies, vaccines, prescription med
Role Description The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA-Manager, the person ensures compliance of study conduct with ICH/GCP and country regulations, our Company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and Systems. - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. - Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. - Gains an in-depth understanding of the study protocol and related procedures. - Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready. - Participates & provides inputs on site selection and validation activities. - Performs remote and on-site monitoring & oversight activities using various tools to ensure: - Data generated at site are complete, accurate and unbiased. - Subjects’ right, safety and well-being are protected. - Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. - Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out. - Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. - Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA-Manager, CRM, TA Head and CRD as needed. - Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites. - Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. - Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required. - Supports and/or leads audit/inspection activities as needed. - Performs co-monitoring visits where appropriate. - Following the country strategy defined by CRD and/or CRA-Manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities. Qualifications - Associate's degree, certificate or equivalent in a scientific / healthcare discipline together with at least 5 years of relevant experience in the healthcare field, including at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO. - Or Bachelor's degree (or above) together with at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO. Requirements - Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively. - Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines. - Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. - Hands on knowledge of Good Documentation Practices. - Proven Skills in Site Management including management of site performance and patient recruitment. - Demonstrated high level of monitoring skill with independent professional judgment. - Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices. - Ability to understand and analyze data/metrics and act appropriately. - Capable of managing complex issues, works in a solution-oriented manner. - Performs root cause analysis and implements preventative and corrective action. Benefits - Comprehensive package of benefits including medical, dental, vision healthcare and other insurance benefits (for employee and family). - Retirement benefits, including 401(k). - Paid holidays, vacation, and compassionate and sick days. - Annual bonus and long-term incentive eligibility, if applicable.
Headquartered in Kenilworth, New Jersey, Merck is a global pharmaceuticals company offering products that include biologic therapies, vaccines, prescription med
Role Description CANDIDATE MUST RESIDE IN ONE OF THE FOLLOWING LOCATIONS: Texas, Illinois, Indiana, Ohio, Tennessee. Ophthalmology experience required. The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA-Manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems. Responsibilities include, but are not limited to: - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. - Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. - Gains an in-depth understanding of the study protocol and related procedures. - Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready. - Participates & provides inputs on site selection and validation activities. - Performs remote and on-site monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased and subjects’ right, safety and well-being are protected. - Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. - Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out. - Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. - Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA-Manager, CRM, TA Head and CRD as needed. - Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites. - Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. - Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required. - Supports and/or leads audit/inspection activities as needed. - Following the country strategy defined by CRD and CRA-Manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities. - Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate. - Could perform Quality control visits if delegated by other roles and trained appropriately. Extent of Travel: - Ability to travel domestically and internationally approximately 65%-75% of working time. - Expected travelling 2-3 days/week. - Current driver’s license required. Qualifications - Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively. - Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines. - Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. - Demonstrated ability to mentor/lead. - Hands on knowledge of Good Documentation Practices. - Proven Skills in Site Management including independent management of site performance and patient recruitment. - Demonstrated high level of monitoring skill with independent professional judgment. - Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices. - Ability to understand and analyze data/metrics and act appropriately, also in a virtual environment. - Experience with conducting site motivational visit designed to boost site enrollment. - Capable of managing complex issues, works in a solution-oriented manner. - Performs root cause analysis and implements preventative and corrective action. - Capable of mentoring junior CRAs on process/study requirements and is able to perform co-monitoring visits where appropriate. Requirements - Associate’s degree, certificate or equivalent in a scientific / healthcare discipline together with at least 7 years of relevant experience in the healthcare field, including at least 4 years of direct site management (monitoring) experience in bio / pharma / CRO. - 5 years Ophthalmology experience required. Retina experience preferred. - Or Bachelor’s degree (or above) with at least 4 years of direct site management (monitoring) experience in a bio / pharma / CRO. - 5 years Ophthalmology experience required. Retina experience preferred. Benefits - Comprehensive package of benefits including medical, dental, vision healthcare and other insurance benefits (for employee and family). - Retirement benefits, including 401(k). - Paid holidays, vacation, and compassionate and sick days.
Founded in 2004 and led by CEO Steve Chapman, Natera is a company in the biotechnology market that offers genetic testing and diagnostics on a global scale. Ope
• Design and review statistical methodology in protocols and statistical analysis plans. • Lead execution of statistical analyses according to plans and protocols, as well as exploratory or ad-hoc analyses. • Produce high quality presentations and author documentation of analysis plans, methods, results, and interpretation. • Effectively convey statistical concepts and results to cross-functional internal and external collaborators and stakeholders. • Identify risks, communicate concerns, and champion solutions to interdisciplinary project teams. • Mentor and provide technical supervision to junior team members. • Perform other duties as assigned.
• Perform in a lead Biostatistician role and provide technical expertise as a core team member of high complexity clinical studies, including statistical oversight and attending relevant project meetings. • Provide expert level statistical guidance and thought leadership for innovative study design and clinical development plans, including endpoint selection powering. • Develop the statistical sections of the study protocol for clinical studies. • Responsible for interpreting analysis results and ensuring reporting accuracy in study reports and regulatory documents. • Conduct overall statistical review of TFLs for clinical studies. • Manage operations work with internal statistical programmers to ensure timeliness and quality of deliverables. • Represent Biostatistics in interactions with regulatory authorities (e.g FDA) and during audits. • Support the preparation of abstracts, oral presentations, manuscripts and written reports by ensuring the results of clinical programs and studies are effectively communicated to internal and external stakeholders. • Provide statistical expertise to internal and external stakeholders (e.g., presentation/publication, Marketing, Health Economics & Reimbursement). • Create, maintain, and implement SOPs, processes, standards, and work instructions with respect to biostatistics to ensure compliance, accuracy, efficiency, and optimization.
• The Manager Clinical Trial Management (MCTM) offers an additional development path for clinical research professionals. Responsibilities focus on the management and career development of the organization’s Clinical Trial Managers (CTM, Sr. CTM, and Principal Clinical Trial Managers (PCTM) , as well as supporting the development of departmental initiatives to strengthen the quality and productivity of Clinical Trial Management operations. • This position requires the ability to independently lead, manage, and motivate a team of CTMs (employee and/or consultant) to a standard consistent with Precision for Medicine’s values and overall focus on quality. The Manager will ensure studies are conducted in accordance with applicable SOPs, regulations, and ICH GCP principles. • Develop, mentor, coach and manage CTMs, and PCTMs to progress their skillset as per Precision for Medicine quality standards. Advocate individual growth and career development • Work with the Clinical Operations Management Team and management of other functional areas to continually improve and enhance CTM expectations and procedures to promote quality, consistency and efficiency while achieving established Key Performance Indicators (KPIs) • Collaborate with the Resourcing team to ensure Clinical Operations resource allocations and needs are appropriately met • Generate action plans and provide developmental/strategic oversight to optimize CTM services, with a focus on high quality delivery of individual/team/departmental goals • Provide on-going feedback and development to manage the performance of direct reports. • Provide technical support and guidance (including scope definition, risk identification, escalation and mitigation, resource planning, goals, and deliverables) to assigned CTMs • Ensure all assigned CTMs have the proper resources, training, materials, and access to systems to deliver on the expectations of their position • Ensure CTMs uphold high quality standards and maintain compliance with established SOPs, working guidelines, project plans and all regulatory requirements • Ensure CTMs provide timely and accurate updates of all required administrative material (SOPs, T&E, etc.) on company systems. • Recognize, exemplify, and adhere to Precision’s values that center on our commitment to quality, our people, clients, and performance • Perform other duties and departmental initiatives as assigned by Leadership
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Python, Google Cloud Platform