Note: The job is a remote job and is open to candidates in USA. ProTrials Research, Inc. is a women-owned, WBENC-certified Contract Research Organization that has been a trusted partner in clinical research since 1996. The Lead Clinical Research Associate (LCRA) is responsible for providing direction and leadership to the Clinical Research Associate team, ensuring accurate and timely study management and monitoring.
Responsibilities
- 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
Skills
- 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
Benefits
- Full medical, dental, and vision insurance options for you and your family
- Flexible PTO so you can take care of what matters, both personally and professionally
- 401(k) plan includes a company match to help you reach your financial goals
- Support and opportunities you need to keep moving forward
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