Lead Clinical Research Associate
ProTrials Research Inc.
contract
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $135,000 - $159,000 per year
Job Level
About the role
- 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
- Guide and support CRAs, CTAs, and external contract research organizations regarding monitoring, co-monitoring, training, and audit visits; review site visit reports and monitoring letters in accordance with study and SOP requirements
- Manage oversight of the Trial Master File (TMF)/eTMF and assist with filing and quality control
- Track serious adverse events, protocol deviations, enrollment, ICFs, study contacts, investigational supplies, and investigational product for assigned study and review with appropriate members of the study team
- Perform qualification, initiation, interim, and close out visits and provide visit reports as per monitoring guidelines as needed
Requirements
- RN, Bachelor, or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education, and training
- Previous CRA experience preferred
- Proven excellence in professional skills including communication, organization, prioritization, presentation, discretion, and accuracy
- Solutions-oriented approach to problem solving
- Familiarity with medical and pharmaceutical industry, and related terminology and practices
- Extensive knowledge of Food and Drug Administration regulations and their practical implementation
- Willingness to travel and perform remote and on-site monitoring, if needed
- Proficiency in Microsoft Word, Excel, and PowerPoint
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical monitoringclinical plans managementdata report reviewsite managementmonitoring guidelinesTrial Master File (TMF) managementadverse event trackingprotocol deviation trackingqualification visitsclose out visits
Soft Skills
communicationorganizationprioritizationpresentationdiscretionaccuracyproblem solvingteam supporttraining developmentcompliance assurance
Certifications
RNBachelor's degreeadvanced degree in biological sciences