Clinical Research Remote Jobs in Texas (US)

This page tracks remote clinical research openings that are location-eligible for Texas.

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1,725

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$98,400 - $126,000

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1725 Jobs

634 Companies

Manager, Clinical Research Monitoring

Edwards Lifesciences

Global leader in the medical device industry with a patient-focused culture of innovation

Clinical Research7 hours ago

Full Time Remote LeadTeam 10,001+Since 1958H1B Sponsor

Company Site LinkedIn

• Providing input on strategic direction on field monitoring of studies and data collection for clinical trials with increased volume and complexity (e.g., KOL site), acting as a Core Team lead • Assessing all data documentation, reports, records, transcripts, exam results for consistency with case report form • Determining if clinical trial/study subject documentation is within parameters of study hypothesis • Monitoring clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements • Participating and contributing to the development of clinical protocols, informed consent forms, and case report forms • Leading in the development of technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities • Acting as a mentor to new or junior level employees • Providing direction and guidance to execute project deliverables in collaboration with project managers • Identifying and evaluating clinical process improvement opportunities • Overseeing clinical trial conduct including management of metrics (e.g., dashboard), compliance, protocol deviations, and data entry cadence • Participating in the development and validation of case report forms • Reviewing monitoring visit reports • Resolving complex trial/study data and regulatory documentation discrepancies escalated by junior level employees • Reviewing and completing checklist on informed consent forms (ICF)

Google Cloud Platform

View details: Manager, Clinical Research Monitoring

United States

$126K - $178K / year

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Clinical Research Finance & CTMS Specialist

Gastro Health

Gastro Health is a large, diverse group of professionals dedicated to digestive health. Visit us at GastroHealth.com

Clinical Research8 hours ago

Full Time Remote Mid LevelTeam 1,001-5,000H1B No Sponsor

Company Site LinkedIn

Role Description The Clinical Research Finance & CTMS Specialist will support the financial, operational, and documentation needs of our growing clinical research program. This role will report to the Finance Department, while working closely with Clinical Research leadership, site managers, coordinators, investigators, sponsors, CROs, and external financial partners. Responsibilities - Clinical Research Finance - Support financial oversight of active clinical trials across Gastro Health research sites. - Track study revenue, earned revenue, open receivables, unpaid invoices, and outstanding sponsor/CRO payments. - Assist with sponsor invoicing, pass-through cost tracking, start-up fee tracking, milestone billing, visit-based billing, and closeout reconciliation. - Review study budgets and payment terms to ensure that billable items are properly captured and invoiced. - Monitor accounts receivables and assist with collections follow-up for unpaid sponsor and CRO balances. - Work with Finance and Clinical Research leadership to reconcile CTMS financial activity against internal accounting records. - Identify missed billing opportunities, underpaid items, payment discrepancies, and budget-to-payment variances. - Support monthly financial reporting for the research program, including revenue, collections, aging, and study-level financial performance. - Internal monthly reporting to clinical research sites on studies/performance, distributions, etc. - Assist in developing standardized finance workflows for clinical trial billing, invoicing, reconciliation, and collections. - RealTime CTMS Administration and Financial Tracking - Use RealTime CTMS to support study financial tracking, visit tracking, invoiceable events, payment status, and revenue reconciliation. - Ensure study budgets, visit calendars, invoiceables, and payment schedules are accurately entered and maintained in RealTime CTMS. - Partner with site staff to ensure completed visits, procedures, stipends, screen failures, unscheduled visits, and protocol-required activities are properly documented and financially captured. - Create and maintain CTMS reports to support Finance, Clinical Research leadership, and site-level operational review. - Identify gaps in CTMS utilization and help standardize how sites document visits, invoiceables, and financial events. - Support training of research staff on financial workflows within RealTime CTMS. - Research Billing and Collections - Support accurate research billing workflows by helping distinguish sponsor-paid services, standard-of-care services, pass-through expenses, and patient-billable items. - Assist with review of clinical trial billing activity to reduce missed charges, duplicate billing, or inappropriate patient billing. - Work with operational teams to ensure financial documentation supports billing and collection activity. - Coordinate with sponsors and CROs on payment status, invoice disputes, remittance details, and payment reconciliation. - Escalate unresolved payment issues to Finance and Clinical Research leadership as appropriate. - Help create a consistent process for tracking payments from invoice generation through receipt and reconciliation. - Source Document Development - Build and maintain protocol-specific source document templates for clinical trials. - Translate protocol schedules of assessments into practical visit worksheets, checklists, and source forms for site use. - Ensure source documents support clean data capture, protocol compliance, billing accuracy, and visit reconciliation. - Work with coordinators, investigators, and quality/regulatory staff to ensure source documents align with protocol requirements, EDC needs, and study workflows. - Update source documents when protocols are amended or operational needs change. - Support standardization of source document templates across Gastro Health research sites. - Cross-Functional Collaboration - Work closely with Finance, Clinical Research Operations, Regulatory, site coordinators, investigators, and external vendors. - Support communication between research sites and Finance to ensure timely and accurate financial reporting. - Assist with onboarding and training of research personnel related to CTMS use, source documentation, billing triggers, and finance workflows. - Participate in study start-up planning to ensure budgets, source documents, CTMS calendars, and financial workflows are established before activation. - Help build scalable infrastructure as Gastro Health expands its clinical research portfolio. Qualifications - Bachelor's degree in finance, accounting, healthcare administration, life sciences, or a related field preferred; equivalent experience will be considered. - 3-5 years of Clinical Research experience required. - Prior work in clinical research operations, clinical research finance, research billing, or CTMS administration. - Hands-on use of RealTime CTMS or a comparable clinical trial management system. - Tracking accounts receivable, payment status, sponsor collections, or study-level financial performance. - Development or maintenance of clinical trial source documents, worksheets, or visit templates. - Work with coverage analysis, charge review, payment reconciliation, or clinical trial revenue cycle workflows. - Work in GI, hepatology, IBD, MASH/MASLD, or other specialty clinical trials. - Work within a multi-site clinical research organization. - Understanding of clinical trial budgets, sponsor invoicing, visit-based payments, pass-through costs, screen failure payments, and start-up fees. - Ability to read clinical trial protocols, schedules of assessments, and study budgets. - Proficiency with Microsoft Excel, SmartSheets and standard business productivity tools. - Familiarity with clinical research compliance, GCP, HIPAA, and sponsor/CRO audit expectations. - Availability to travel as required. Benefits - Medical - Dental - Vision - Spending Accounts - Life / AD&D - Disability - Accident - Critical Illness - Hospital Indemnity - Legal - Identity Theft - Pet - 401(k) retirement plan with Non-Elective Safe Harbor employer contribution for eligible employees - Discretionary profit-sharing with employer contributions of 0% - 4% for eligible employees

View details: Clinical Research Finance & CTMS Specialist

United States

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Clinical Review Dentist

UnitedHealth Group

UnitedHealth Group is a healthcare and well-being company that’s dedicated to improving the health outcomes of millions around the world. We are comprised of

Clinical Research16 hours ago

Full Time Remote Mid Level

Company Site

Role Description The Clinical Review Dentist is a production role that supports the dental director on claims review. Strong knowledge of dental procedures, terminology and related dental codes along with strong computer and communication skills are crucial to this role. You’ll enjoy the flexibility to work remotely from anywhere within the U.S. as you take on some tough challenges. - Review of claims and supporting clinical data to provide accurate documentation for the dental director - Accurate interpretation of radiographs, intra-oral photographs and clinical narratives - Maintain organization and department defined standard of performance to meet metrics - Communication with provider offices in accordance with compliance regulations to discuss adverse clinical determinations and to request missing information - Independently manage individual queue assignments and workflow to meet deadlines, business needs and department and individual metrics - Acts as a liaison between our dental directors and provider offices to maintain provider/member satisfaction - Perform individual case review for appeals and grievances related to adverse determinations for dental services - Participate in peer-to-peer calls with dental providers The work hours for this position will be from 10 am-7 pm CST and will include 8 hours of coverage every 4th Saturday/Sunday. Working during the weekend will give you a day off during the week. You’ll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in. Qualifications - Dental degree from an Accredited Dental School - Active dental license - 7+ years of experience in clinical dentistry - 3+ years dental benefit plan experience with specific exposure to claim review and utilization management or comparable experience - Ability to pass a credentialing review for practice experience - Computer proficiency - Excellent business analytical and writing skills Requirements - Experience with Dental Compliance related to Federal Regulations - All employees working remotely will be required to adhere to UnitedHealth Group’s Telecommuter Policy Benefits - Comprehensive benefits package - Incentive and recognition programs - Equity stock purchase - 401k contribution (all benefits are subject to eligibility requirements) - Salary range from $112,700 to $193,200 annually based on full-time employment Application Deadline This will be posted for a minimum of 2 business days or until a sufficient candidate pool has been collected. Job posting may come down early due to volume of applicants.

View details: Clinical Review Dentist

United States

$112.7K - $193.2K / year

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Clinical Placement Specialist

Northern Kentucky University

Northern Kentucky University, based in Highland Heights, Kentucky, is a public institution of higher learning located near Cincinnati, Ohio. With roots dating b

Clinical Research23 hours ago

Full Time Remote Senior

Company Site

Position Title: Clinical Placement Specialist Location: United States Work Type: Remote, Full Time Job ID: JR100152 Job Description: The Clinical Placement Specialist supports the coordination and placement of Nurse Practitioner (NP) students into clinical rotations within the Master of Science in Nursing (MSN) program. This role is responsible for high volume preceptor outreach, managing placement data, ensuring student compliance, and collaborating with internal stakeholders to secure timely and appropriate clinical placements. The position is critical to maintaining accreditation standards and ensuring all students meet required clinical experience requirements. Primary Responsibilities - Conduct high-volume outreach to potential preceptors, initiating and maintaining communication to secure student clinical placements - Manage and monitor NP Preceptor email inbox, organizing and responding to inquiries within established timeframes - Develop and maintain detailed, term-specific spreadsheets to track student placement needs, including specialty, location, and compliance status - Coordinate student placements by tracking prior placements, current needs, and placement outcomes - Monitor and update placement statuses, including approvals, declines, and pending opportunities - Collaborate with the Student Placement Coordinator to track and address student compliance requirements using systems such as Sentry and Precheck - Maintain and update preceptor outreach data, ensuring accuracy of contact information, outreach efforts, and placement outcomes - Generate weekly reports on placement progress, including student placement status, compliance issues, and outstanding needs - Participate in team meetings to review student needs and identify placement opportunities - Communicate placement matches and required documentation to students and preceptors - Assist with managing Placement Graduate Assistant, providing guidance and support for outreach activities - Support leadership within Clinical Operations and Outreach with ongoing placement and reporting needs Knowledge Skills & Abilities - Strong organizational and time management skills with the ability to manage multiple priorities simultaneously - Excellent written and verbal communication skills, particularly in professional outreach and follow-up - Ability to perform high-volume outreach while maintaining attention to detail and accuracy - Proficiency in spreadsheet management and data tracking (e.g., Excel or similar tools) - Strong analytical skills to track, interpret, and report placement data - Ability to work collaboratively within a team environment and across departments - Problem-solving skills and ability to manage urgent placement needs effectively - High level of attention to detail, particularly in compliance tracking and documentation - Ability to maintain confidentiality and handle sensitive information Education & Experience - Minimum: Bachelor's degree; Healthcare administration, business administration, education, or a related field preferred - Minimum of 1-3 years of experience in healthcare, higher education, clinical coordination, recruitment or administrative support role - Experience with data tracking systems, Microsoft Office - Experience working with clinical placements, healthcare providers, Medatrax, or academic programs strongly preferred Posted Salary: Work Environment & Physical Demands: This position primarily operates in a remote environment and requires prolonged periods of sitting and working at a computer. The role involves repetitive tasks such as email communication and spreadsheet management. Occasional standing, walking, and light lifting (up to 10 pounds) may be required. The position also requires the ability to maintain focus and productivity during high-volume, detail-oriented work.

View details: Clinical Placement Specialist

United States

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Senior Clinical Research Associate

Veranex, Inc.

Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.

Clinical Research1 day ago

Full Time Remote SeniorTeam 1,001-5,000

Role Description Veranex has an exciting opportunity to join our team as a Senior Clinical Research Associate to support our Clinical Operations team. The Sr. CRA will participate in the planning, development, and execution of clinical trials to evaluate the safety, effectiveness, and performance of medical devices. Under management supervision, the Sr. CRA will monitor assigned clinical trials to ensure adherence to the clinical protocol, applicable regulations, and company Standard Operating Procedures (SOPs) governing clinical studies. Location: Remote, US What You Will Do - Ensure that study investigators and coordinators comply with the study protocol, Good Clinical Practices (GCPs), Code of Federal Regulations (CFRs), and Institutional Review Board (IRB)/Ethics Committee (EC) requirements during clinical studies by training/guidance of investigators/research coordinators, conducting periodic on-site evaluations and follow-up of corrective actions. - Act as primary liaison to clinical sites. - Conduct site qualification visits, study start-up activities (essential document collection), site initiation visits and training, monitoring visits for source data verification, and site close-out visits. - Generate high-quality site qualification, initiation, monitoring, and close-out visit reports in a timely manner (in accordance with the Clinical Monitoring Plan). - Contribute to protocol, informed consent, case report form (CRF) and study plan development as well as annual progress reports (APRs) and the clinical study report (CSR) at study conclusion to report the study results to FDA and other regulatory authorities. - Ensure that the rights and well-being of human subjects are protected and confirm data quality/integrity by maintaining site compliance, reviewing adverse events and device deficiencies, reviewing data trending/metrics, reviewing audit reports, and implementing corrective actions as necessary. - Support maintenance of department SOPs and work instructions. - Support investigational device traceability including documentation for forecasting, shipping, receipt, and disposition. - Support and maintain documentation of all clinical research activities in the study trial master file (TMF), e.g., monitoring reports, site correspondence, device inventory information. - Drive trial enrollment and identify and communicate potential and actual obstacles to enrollment. - Travel requirement: 25-50%. Qualifications - Minimum of 5 years of directly related work experience or equivalent in clinical research, including work on medical device significant risk IDE trials and/or non-significant risk abbreviated IDE trials. - Must be able to work autonomously and as a member of a cross-functional team and meet high expectations and tight deadlines. - Must have working knowledge of Good Clinical Practices (GCPs), FDA regulations, and IRB requirements. - Must have strong project management competencies and ability to work with high quality, reliability, and attention to detail. - Must have a strong level of professionalism, including verbal and written communication skills; and the ability to communicate with all levels of the organization, cross-functionally, and with clients/partners. - Must have proficiency in using Microsoft Office Suite, including Word, Excel, Outlook, and PowerPoint; as well as experience with electronic data capture (EDC) and electronic Trial Master File (eTMF) systems. - Experience interfacing successfully with physicians/clinical staff and familiarity with hospital/clinical environments. - Familiarity with medical and anatomical terminology. - Ability and willingness to travel. Preferred - BS or BA degree preferred; BS or BA in a relevant scientific discipline or related field also preferred. Company Description Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.

View details: Senior Clinical Research Associate

United States

$98.4K - $140.7K / year

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Senior Specialist, Clinical Research Monitoring

Edwards Lifesciences

Global leader in the medical device industry with a patient-focused culture of innovation

Clinical Research1 day ago

Full Time Remote SeniorTeam 10,001+Since 1958H1B Sponsor

Company Site LinkedIn

Role Description Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you will make an impact: - Field monitoring of studies and data collection for clinical trials. - Assessing all data documentation, reports, records, transcripts, exam results for consistency with case report form. - Determining if clinical trial/study subject documentation is within parameters of study hypothesis. - Monitoring clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements. - Developing and delivering technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements. - Training and proctoring new employees on trial and study related activities. - Acting as a mentor to new or junior level employees. - Providing oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff. - Supporting study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Boards, Contract, and Training, developing process improvements. - Contributing to the development of clinical protocols, informed consent forms, and case report forms. - Validating investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition. - Verifying trial/study data, including maintaining appropriate regulatory documents both internal and external. - Auditing to ensure the site has the appropriate regulatory documentation to conduct the trial/study. - Ensuring source documentation is properly recorded. - Editing/amending informed consent documents. Qualifications - Bachelor's Degree or equivalent in related field with 5 years of field monitoring, quality assurance/control and regulatory compliance experience or equivalent work experience based on Edwards criteria. - Ability to travel up to 75% domestically. Requirements - Clinical research certification (ACRP or SoCRA clinical coordinator / CRA certification) (Preferred). - Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills (Preferred). - Demonstrated problem-solving and critical thinking skills (Preferred). - Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery (Preferred). - Excellent understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise (Preferred). - Moderate understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting (Preferred). - Technical writing skills (protocols, CRF development, study tools) (Preferred). - Ability to communicate and relate well with key opinion leaders and clinical personnel (Preferred). - Experience in training new hires (Preferred). Benefits - Competitive salaries. - Performance-based incentives. - A wide variety of benefits programs to address the diverse individual needs of our employees and their families. Company Description Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement: Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

View details: Senior Specialist, Clinical Research Monitoring

United States

$108K - $153K / year

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Principal Biostatistician

IQVIA

IQVIA is a publicly-traded healthcare intelligence company founded in 2016 upon the merger of two market leaders: Quintiles and IMS Health. With locations aroun

Clinical Research1 day ago

Full Time Remote Lead

Company Site

Role Description The Principal Biostatistician is responsible for providing statistical support for Phase 1, 2 and 3 pharmaceutical clinical trials in patients, focusing on safety endpoints and outcomes. Job Responsibilities - Support Safety Analytics with ADaM/TFL standard development of safety deliverables, including specialty areas such as Hypersensitivity, Injection/Infusion Site Reaction. - Support Safety Analytics and the study team on the delivery of Patient Profile display for Hepatic or other areas. - Provide ADaM/TFL/interactive package review support for the Safety Analytics team supported portfolio deliveries, including cross-checks between interactive outputs and TFLs. - Interrogating root cause of issues identified during ADaM/TFL/Interactive package review. - Providing statistical leadership and support for safety analyses for Phase 1/2/3 trials. - Collaborate with multi-disciplinary project teams to establish project objectives and timelines. - Participating in study design discussions, including protocol development. - Write the statistical sections of clinical trial protocols. - Reviewing CRFs, data review guidelines, and related study documentation to ensure statistical and safety considerations are appropriately addressed. - Developing and reviewing statistical analysis plans and TFL templates. - Monitor internal and CRO project activities including timelines, deliverables, and availability of resources. - Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise. - Contribute to clinical study reports and other regulatory documents, e.g. NDA, DSURs, Briefing Documents, ISS, ISE, etc. - Serving as an unblinded DMC statistician across multiple studies, ensuring compliance with sponsor and regulatory requirements. - Provide guidance and supervision to programmers in authoring analysis dataset specifications and programming/validation of tables, listings, and figures. - Perform exploratory safety analyses. - Perform validation of analysis variables and statistical outputs. - Interpret study results and review reports of study results for accuracy. - Present, communicate and interpret safety analyses to study teams. - Support exploratory analyses. - Participate in pre-IND or NDA activities. Qualifications - PhD in Statistics, Biostatistics, or related field with 3+ years industry experience. - MS in Statistics, Biostatistics, or related field with 5+ years of industry experience. - At least 2 years of Phase 1, 2 and 3 clinical trial experience. - Strong experience reviewing ADaM datasets and TFLs (standard and customized output review). - Ability to follow data specifications and programming specifications and provide clear, actionable review comments. - Able to investigate and troubleshoot mismatches between tools/outputs (e.g., Spotfire vs. SAS TFL) by interrogating programs to identify root cause and errors. - Strong communication and time management: provide realistic timeline estimates, flag risks/delays early, and ask the right questions to move work forward. - R/SAS programming skills. - Demonstrated ability to work pro-actively and independently. - Able to effectively communicate his/her ideas and to manage programmers in a constructive manner. - Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards. - Experience with CDISC SDTM and CDASH. Desired Experience - Leading DSBM or DMC for biostatistics. Benefits - Home-based remote working opportunities. - Work/life balance as well as flexible schedules. - Collaborating with motivated, high-performance, statistical and research teams. - Technical training and tailored development curriculum. - Research opportunities that match your unique skillset. - Promising career trajectory. - Job stability: long-term engagements and re-deployment opportunities. - Focus on bringing new therapies to market rather than project budgets and change orders. - Experience with regulatory submissions. - Engaging, fast-paced environment. - Good work-life balance.

View details: Principal Biostatistician

United States + 1 more

$111K - $309K / year

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Senior Clinical Trial Manager

Parexel

Clinical Research1 day ago

Full Time Remote LeadTeam 10,001+Since 1983H1B Sponsor

Company Site LinkedIn

Role Description The Senior Clinical Trials Manager (Sr. CTM) will be a member of the client’s Clinical Operations team. - Oversight of activities - Manage complex Phase 1, 2, 3, and 4 clinical trials as part of a global clinical operations team. - Demonstrate oversight of CROs and work in a quality framework that supports confirmatory trials. - Provide direction and leadership in CRO and vendor selection and management. - Knowledge of regulatory start up process and planning in support of study start up. - Managing and maintaining high performing clinical teams. - Coordination of global clinical trials. - Provide technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct. - Coordinate closely with Clinical Development, Biostatistics, Data Management, Drug Safety, Legal, Finance, Product Development, Project Management and Regulatory to ensure operational excellence. - Be responsible for and manage clinical research activity of Clinical Operations team. - Estimate, track and critically analyze vendor financial spend on study. - Analyze and develop action plans to address issues with investigational sites, CRAs, and CROs. - Provide guidance, direction, and management to site monitoring activity. - Coordinate patient enrollment activities and mitigation planning. - Coordinate study supplies with regulatory and clinical supplies functions. - Negotiate contracts with vendors of clinical trial services. - Review Informed Consent Forms, CRFs, and study related materials. - Plan and participate in investigator meetings. - Assist and support data query process. - Assure regulatory compliance of investigational sites with client’s SOPs and FDA and ICH guidelines. - Ensures trial master file is current and maintained. - Collaborate in the management of external vendors and contract research organizations to ensure efficient execution of clinical trials. - Collaborate in the development of programming specifications. Qualifications - Excellent oral and written communication skills and strong organizational abilities. - Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook). - Demonstrated ability to work independently and in a team environment. - Ability to prioritize and manage multiple tasks simultaneously. - Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands. Requirements - Proven experience of clinical trial management. - Proven management of people in a matrixed environment. - Experience in CNS and/or oncology is preferred. - Management of global clinical trials. - Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations. - Travel required. Must be willing to travel 15-25%, including international travel. - Proven track record with relevant clinical trials experience, including strong performance as a CRA in the pharmaceutical industry (i.e. biotechnology, pharmaceutical, CRO, medical device). Education - BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred.

View details: Senior Clinical Trial Manager

United States + 1 more

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Travel Clinical Research Coordinator

Alcanza Clinical Research

Clinical Research for All℠

Clinical Research1 day ago

Full Time Remote Mid LevelTeam 201-500H1B No Sponsor

Company Site LinkedIn

• In collaboration with other members of the clinical research site team works to ensure the execution of assigned studies. • Responsibilities may include but are not limited to: - Screening of patients for study enrollment; - Patient consents; - Patient follow-up visits; - Documenting in source clinic charts; - Entering data in EDC and answering queries; - Obtaining vital signs and ECGs; - May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up; - Requesting and tracking medical record requests; - Updating and maintaining logs, chart filings; - Maintaining & ordering study specific supplies; - Scheduling subjects for study visits and conducts appointment reminders; - Building/updating source as needed; - Conducting monitoring visits and resolves issues as needed in a timely manner; - Ensuring study related reports and patient results are reviewed by investigator in a timely manner; - Filing SAE/Deviation reports to Sponsor and IRB as needed; - Documenting and reporting adverse events; - Reporting non-compliance to appropriate staff in a timely manner; - Maintaining positive and effective communication with clients and team members; - Always practicing ALCOAC principles with all documentation; - Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc.; - Prepare and attend site initiation visits (SIV’s) and Investigator Meetings (IMs), as needed; - Handles all IRB functions for assigned studies independently, and/or with assigned regulatory team member, as needed; - Assist with training of new research assistants and coordinators; - Assist with scheduling and planning for visit capacity for assigned studies; - May set up, train and maintain all technology needed for studies; - May assist with study recruitment, patient enrollment, and tracking as needed; - May handle more complex study assignments and volumes; - May participate in community outreach/education events; - Maintaining confidentiality of patients, customers and company information, and; - Performing all other duties as requested or assigned.

View details: Travel Clinical Research Coordinator

Alabama + 11 more

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Clinical Team Lead

Rho, Inc.

Established in 1984, Rho is a full-service contract research - CRO organization that has developed an excellent reputation for providing an "unsurpassed degree

Clinical Research1 day ago

Full Time Remote Lead

Company Site

Role Description We are hiring a Clinical Team Lead! This is a permanent role to work remotely, with the expectation of occasional travel for site visits and client meetings. The Clinical Team Lead (CTL) is responsible for managing and maintaining ownership of the clinical operations aspects of assigned projects. This position is responsible for providing direction and training to CRAs assigned to the project. In addition, the CTL is responsible for the oversight of all operational aspects related to the planning and oversight of CRA and site performance. The CTL is responsible for ensuring that sites and CRAs operate in compliance with study protocols, ICH/GCP guidelines, and Federal Regulations. - Manages the end-to-end clinical execution of projects up to moderate complexity and scope and/or supports a senior-level CTL on more complex or larger scope projects, ensuring adherence to protocols, timelines, and regulatory requirements. - Oversees recruitment, study metrics monitoring, and documentation activities. With guidance, identifies issues and contributes to implementing solutions. - Ensure sites comply with Good Clinical Practice (GCP) and applicable regulations. - Collaborates with cross-functional teams (e.g., data management, regulatory, safety) to facilitate study deliverables. - Develops and manages clinical operation timelines, metrics, resourcing, budget and activities of projects up to moderate complexity and scope. May also support senior CTLs on more complex or larger scope projects. - Identifies potential risks and escalates to appropriate stakeholders, supporting collaboration and leading implementation of appropriate corrective actions and mitigation strategies. - Manages tracking and reconciliation of clinical budgets related to clinical operation activities such as monitoring visit and CRA allocation. Identifies potential budget variances and escalates to appropriate stakeholders to ensure timely corrective actions are taken and cost-effectiveness is maintained. - May assist with RFP strategic planning, budget development, and capabilities/response narratives. - Performs monthly assessment of CRA resourcing projections based on study parameters (e.g., active sites, projected Days On Site, upcoming milestones, etc.). Works with CRA Line Management to proactively confirm resourcing needs. - Serves as the lead clinical liaison among Clients, site staff, and internal teams on projects up to moderate complexity. - Leads internal and external meetings. - Manages routine Client communications and helps manage client expectations. - Communicates and works effectively with site staff, as needed, serving as an escalation point for CRAs as issues arise. - Leads CRAs and IHCRAs, including project training and onboarding. - Creates and conducts training sessions including investigator meetings, conferences, and team training. - Provides constructive performance feedback on CRAs/IHCRAs to line managers and project leads. - May participate in Bid Defense Meetings to present clinical operation and monitoring strategy. - Participates in upfront Protocol Deviation planning and identification, in support of finalization and maintenance of Protocol Deviation Plan and related activities. - Manages protocol deviation review and reconciliation throughout the study, ensuring timely documentation and resolution in collaboration with cross-functional teams and Client for review and approval on projects of up to moderate complexity. - Supports the identification and continuous assessment of clinical risks throughout the study and contributes to the development and implementation of risk mitigations on projects of up to moderate complexity. - Provides skilled review and development of study protocols and study-related documents and materials (e.g., clinical monitoring plan, protocol deviation plan, case report forms). - Oversees and performs on-site Quality Compliance Visits to review data across CRAs using a targeted, adaptive and/or risk-based approach focused on critical and safety related data points. Identifies trends and potential quality issues, escalating as appropriate. Collaborates with CRAs and study teams to implement corrective and preventive actions. Qualifications - Bachelor's Degree, preferably in a life science, nursing, pharmacy or related field. - 5 years of clinical research experience within the CRO, pharmaceutical, or biotechnology industry. - At least 2 years of experience working as a clinical team lead preferred. - At least 2 years of on-site monitoring experience. - Proven leadership capabilities with experience in leading teams within a CRO or pharmaceutical setting. - Strong knowledge of GCP and regulatory requirements, as well as familiarity with clinical trial processes and documentation. - Excellent interpersonal and communication skills, able to build relationships with clients and teams. - Demonstrated ability to manage multiple priorities and deliver on deadlines in a fast-paced environment. - A proactive, solutions-oriented mindset with the ability to drive decisions and lead initiatives. - Experience using clinical trial management software and EDC systems. Benefits - Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.

View details: Clinical Team Lead

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