Lead Clinical Research Associate - Contract Position
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About the role
ProTrials seeks a contract Lead Clinical Research Associate to provide study oversight and leadership for CRA and CTA teams. Responsibilities include monitoring oversight, clinical plans, site visits, training, TMF/eTMF management, quality issue resolution, and study tracking. The role is home-based but requires willingness to travel and perform remote and on-site monitoring when needed.
Key requirements
- • RN, Bachelor, or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education, and training
- • Required skills: Clinical study oversight, Clinical monitoring, Study and project coordination, Clinical monitoring plans and study timelines, Site management, Team leadership and support, Training and development, Trial Master File/eTMF oversight, Serious adverse event tracking, Protocol deviation tracking, Enrollment tracking, Investigational product and supply tracking, Microsoft Word, Excel, and PowerPoint, Communication, Organization, Prioritization, Presentation, Discretion, Accuracy, Problem solving, Familiarity with medical and pharmaceutical industry terminology and practices, Knowledge of Food and Drug Administration regulations and their practical implementation, Willingness to travel and perform remote and on-site monitoring, if needed
Opportunity details
- • Workplace: Remote
- • Employment: Contract
- • Posted: Oct 1, 2026
- • Original advert language: English
Full vacancy
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See original vacancy ↗Employer’s role description
Job title: Lead Clinical Research Associate - Contract Position
Team: Clinical Operations
Location: Home-based
All locations: Home-based
Work type: Contract
Workplace type: remote
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. Founded with a clear mission to deliver high-quality, experienced, and ethical services, we’ve supported research behind innovative treatments in the pharmaceutical, biotech, and medical device industries.
Our people are the heart of everything we do. We believe great work happens when team members feel valued, supported, and empowered. At ProTrials, you’ll join a collaborative community committed to making a meaningful impact on global health.
We are excited to connect with skilled individuals who share our passion for advancing clinical research with care, integrity, and excellence.
ABOUT THE JOB
ProTrials is seeking a Contract Lead Clinical Research Associate to join our team.
The Contract Lead Clinical Research Associate (LCRA) is responsible for providing direction and leadership to the Clinical Research Associate (CRA) team and Clinical Trial Associate (CTA) assigned to studies. The Contract LCRA ensures accurate and timely initiation, enrollment, conduct, completion, and provides project management support. The Contract LCRA ensures adequate study monitoring resources are in place for the study.
The Contract LCRA also identifies quality issues related to clinical monitoring activities, and along with the study team, establishes action plans to address them.
HERE IS WHAT YOU WILL DO:
- Provide study oversight as the primary liaison between CRAs, internal staff, study site staff including investigators, coordinators, client personnel, and external vendors involved in all stages of the study
- Ensure clinical monitoring activities of the study CRA team(s) are performed in accordance with applicable Standard Operating Procedures (SOP), regulations, good clinical practices, key performance indicators, and study-specific requirements
- Develop, review, and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines; ensure compliance with monitoring intervals according to project requirements, review data reports, CTMS, disseminate listings/reports to study CRAs, and work with CRAs and site staff to resolve data discrepancies
- Create annotated visit report templates and other documents and strategies related to site management and monitoring
- Support training and development of team members, ensure compliance with study specific training requirements, and ensure training is appropriately documented
Verification
- ✓ Employer verification
- ✓ Original posting located
- Last verified: Oct 4, 2026