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
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
HERE IS WHAT YOU BRING TO THE TABLE:
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
