**We need a CRA in the Southeast, USA. i.e. GA, FL, NC, SC, etc. Precision for Medicine is not your typical CRO. We are passionate about supporting professional growth and are proud to share extremely high CRA retention rates compared to industry averages. CRAs join us, love their jobs, and stay because of the amazing people and enjoyable quality of life. Travel is reasonable and your work/life balance will benefit as a result. Most meaningfully - your voice will be heard. Working in a midsized CRO allows you to have influence and impact when it matters most with support from direct line management. To support continued growth from our clients, we are hiring all levels of CRAs experienced in monitoring Oncology or Cardiology. Position Summary: The CRA II is a seasoned, experienced professional in monitoring and site management. Responsibilities will be dependent upon the type and timing of the program to which the CRA II is assigned and typically include activities involving start-up and study implementation, on-site monitoring of clinical research studies as well as on-going site management. Incumbents work independently as a study team member. Essential functions of the job include but are not limited to: - Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports. - Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. - Updates, tracks and maintains study specific trial management tools/systems, and status reports. - If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager. - If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee. - Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. - Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote). - Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. - Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. - Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues. - Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image. - Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. - Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies. - Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process. - Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team. - Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. - Travels as necessary according to project needs. - Performs other duties as assigned by management. Qualifications: Minimum Required: - 4-year college degree or equivalent experience in a scientific or healthcare discipline. - Two (2) years or more as a CRA in a CRO or equivalent, relevant experience and/or demonstrated competencies. Site management or equivalent experience in clinical research Other Required: - Excellent communication and organizational skills are essential. A team player. - Evidence of a client focused approach - Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail. - Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed. - Fluency in English and for non-English speaking countries the local language of country where position based Preferred: - Graduate or postgraduate degree - Lupus monitoring experience - Experience monitoring in rare and complex therapeutic areas - Experience monitoring EDC trials and EHR records - Experience in biopharma or relevant therapeutic area - Relevant site start-up (feasibility, contract negotiations, submissions) experience for the particular country - Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines. - Ability to resolve project related problems and prioritizes workload to meet deadlines with minimal support from management. Competencies: - Exhibits self-motivation and is able to work and plan independently as well as in a team environment - Understands clinical trials methodology, including a working knowledge of protocols and indications being studied - Demonstrates professionalism as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills - Collects data of consistently high standard - Demonstrated ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency - Fluency in English and for non-English speaking countries the local language of country where position based About Precision for Medicine Precision for Medicine is a precision medicine CRO. Precision’s uniquely integrated offerings enable the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for complex disease states. Precision medicine is revolutionizing the attack on cancer. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway. We invite you to learn more about our growing organization serving clients that are researching groundbreaking therapies. We strive to ensure employees feel appreciated through a multitude of benefits including paid time off, volunteer time off, robust medical offerings, non-vested 401k plus company match, paid parental leave and more. At Precision, your ideas and contributions are valued and nurtured, impacting positive change for the company. Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits. Reasonable estimate of the current range $91,500—$137,300 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

**We need a CRA in the Southeast, USA. i.e. GA, FL, NC, SC, etc. Precision for Medicine is not your typical CRO. We are passionate about supporting professional growth and are proud to share extremely high CRA retention rates compared to industry averages. CRAs join us, love their jobs, and stay because of the amazing people and enjoyable quality of life. Travel is reasonable and your work/life balance will benefit as a result. Most meaningfully - your voice will be heard. Working in a midsized CRO allows you to have influence and impact when it matters most with support from direct line management. To support continued growth from our clients, we are hiring all levels of CRAs experienced in monitoring Oncology or Cardiology. Position Summary: The CRA II is a seasoned, experienced professional in monitoring and site management. Responsibilities will be dependent upon the type and timing of the program to which the CRA II is assigned and typically include activities involving start-up and study implementation, on-site monitoring of clinical research studies as well as on-going site management. Incumbents work independently as a study team member. Essential functions of the job include but are not limited to: - Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports. - Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. - Updates, tracks and maintains study specific trial management tools/systems, and status reports. - If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager. - If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee. - Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. - Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote). - Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. - Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. - Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues. - Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image. - Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. - Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies. - Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process. - Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team. - Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. - Travels as necessary according to project needs. - Performs other duties as assigned by management. Qualifications: Minimum Required: - 4-year college degree or equivalent experience in a scientific or healthcare discipline. - Two (2) years or more as a CRA in a CRO or equivalent, relevant experience and/or demonstrated competencies. Site management or equivalent experience in clinical research Other Required: - Excellent communication and organizational skills are essential. A team player. - Evidence of a client focused approach - Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail. - Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed. - Fluency in English and for non-English speaking countries the local language of country where position based Preferred: - Graduate or postgraduate degree - Lupus monitoring experience - Experience monitoring in rare and complex therapeutic areas - Experience monitoring EDC trials and EHR records - Experience in biopharma or relevant therapeutic area - Relevant site start-up (feasibility, contract negotiations, submissions) experience for the particular country - Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines. - Ability to resolve project related problems and prioritizes workload to meet deadlines with minimal support from management. Competencies: - Exhibits self-motivation and is able to work and plan independently as well as in a team environment - Understands clinical trials methodology, including a working knowledge of protocols and indications being studied - Demonstrates professionalism as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills - Collects data of consistently high standard - Demonstrated ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency - Fluency in English and for non-English speaking countries the local language of country where position based About Precision for Medicine Precision for Medicine is a precision medicine CRO. Precision’s uniquely integrated offerings enable the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for complex disease states. Precision medicine is revolutionizing the attack on cancer. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway. We invite you to learn more about our growing organization serving clients that are researching groundbreaking therapies. We strive to ensure employees feel appreciated through a multitude of benefits including paid time off, volunteer time off, robust medical offerings, non-vested 401k plus company match, paid parental leave and more. At Precision, your ideas and contributions are valued and nurtured, impacting positive change for the company. Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits. Reasonable estimate of the current range $91,500—$137,300 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Clinical Research Associate/Senior CRA - VA, DC, MD ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. What you will be doing - Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. - Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. - Collaborating with investigators and site staff to facilitate smooth study conduct. - Performing data review and resolution of queries to maintain high-quality clinical data. - Contributing to the preparation and review of study documentation, including protocols and clinical study reports Your profile - Bachelor's degree in a scientific or healthcare-related field. - Minimum of 12 months onsite monitoring experience as a Clinical Research Associate; level (CRA I, CRA II, or Senior CRA) determined by total years of experience. In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. - Strong organizational and communication skills, with attention to detail. - Ability to work independently and collaboratively in a fast-paced environment. - Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver’s license What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: - Various annual leave entitlements - A range of health insurance offerings to suit you and your family’s needs. - Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. - Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. - Life assurance - Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Our culture and people are what set us apart from other post-acute care providers. We’re dedicated to the growth and development of our team to set them up for success. We CARE for our patients like they are our own FAMILY. Schedule: Monday through Friday 8:15am - 5:00pm Location: Remote The OASIS Review Specialist (ORS) reviews clinical documentation to identify opportunities for improvement. The OASIS Review Specialist is responsible for reviewing and revising OASIS and other documentation for accuracy and compliance and collecting data to identify opportunities for improvement; the ORS should have extensive knowledge of the regulatory guidelines governing home health agencies and complies with all agency policies and legal rules and regulations. QUALIFICATIONS: - Registered Nurse, Therapist, Licensed Practicing Nurse or Therapy Assistant - Training and experience in Quality Improvement activities required - Minimum 3 years in Home Care or related health programs. - OASIS review experience is a plus - Knowledge of guidelines governing home health agencies, including CMS & OASIS Rules and Guidelines - Knowledgeable of nursing best practices. - Comfortable learning new software and database systems. - Intermediate to advance level of Microsoft Word, Excel, PowerPoint and Outlook - Observant and detail oriented. - Ability to multi-task and prioritize. - Ability to track and analyze data. - Ability to create positive impressions and communicate with a variety of people. - Personable and courteous working relationships. - Ability to follow directions and work as a team member. - Communicates effectively with team members. - Maintains a professional appearance as a representative of the company. MAJOR AREAS OF RESPONSIBILITY: - Reviews OASIS and patient records as they appear in workflow to identify opportunities to improve patient care, accuracy and/or documentation - Ensures accuracy with OASIS guidelines and other applicable rules and regulations - Reviews charts to monitor compliance with regulatory and governmental regulations - Performs comprehensive audits of clinical and administrative functions as assigned - Ability to process, interpret & display data daily utilizing QI methodology according to assigned timeframes based upon business needs. - Meets the productivity standards and workflow expectations set by the department - Functions as a resource for clinicians, agency staff and internal staff - Collaborates with clinician as necessary should the OASIS and/or clinical documentation need to be amended - Meets the objective of Quality Measures and Process Measures - Attends in-service trainings and mandatory agency meetings - Understands and practices agency policies and procedures - Stays current with CMS guidelines - Read and adhere to all Agency Policies and Procedures and follow Employee Handbook Guidelines - Actively promote the values, mission and culture of the Company - Completes and submits all required documentation within specified company requirements - Other duties as assigned #INDASHN3 We’ll help you put your passion for patient care to work. Apply today! This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice. We are an Equal Opportunity Employer.