Job DescriptionSummary:The Senior Clinical Research Associate (Sr. CRA) is an experienced clinical operations professional responsible for managing site monitoring and relationship activities across multiple clinical studies. This role serves as a key resource to study teams, ensuring high-quality study execution, adherence to Good Clinical Practice (GCP), regulatory requirements, and company standards. The Sr. CRA provides guidance to less experienced CRAs, supports investigator sites, proactively identifies and resolves operational issues, and contributes to the successful delivery of clinical study objectives.
The Sr. CRA will practice excellent written and verbal communication skills, including medical terminology. In this role the candidate will display strong presentation, organizational, time-management, and prioritization skills. Being technically savvy with the ability to leverage technology to drive efficiency and performance while working independently with minimal supervision in a fast-paced environment will be key.
Responsibilities: Study & Site Management
- Serve as CRA for assigned complex clinical studies, providing expert oversight of site selection, initiation, monitoring, and close-out activities (on-site, virtual, remote).
- Actively participate in site feasibility assessments and site selection processes.
- Ensure study conduct is executed according to the clinical protocol, regulatory requirements (GCP, FDA, ISO), IRB/EC requirements, and company SOPs.
- Prioritize patient safety, ensuring informed consent and study procedures are performed accurately and ethically.
- Review and report AEs/SAEs and protocol deviations in accordance with regulatory and company requirements.
- Maintain complete, accurate, and audit-ready regulatory documentation and TMFs in accordance with ALCOA principles.
- Monitor site inventory of investigational products and study supplies.
- Proactively identify, communicate, and manage study risks and issues to ensure operational continuity and compliance.
Monitoring & Documentation
- Author, review, and approve Monitoring Plans, study source documents, monitoring tools, and site-facing training materials.
- Perform SDR/SDV per monitoring plans and document monitoring activities through timely, high-quality trip reports.
- Ensure compliance with company travel and expense policies.
Leadership & Mentorship
- Provide mentoring, training, and functional oversight of CRAs, including contingent (contract) CRAs.
- Lead or review functional job aids and training materials.
- Present confidently and contribute to extended functional and study team meetings, providing clear updates on site status, risks, and issues.
Systems & Collaboration
- Utilize and maintain accurate study data in clinical systems, including Veeva Vault CTMS and CDMS.
- Work cross-functionally with internal teams and CROs to ensure high-quality study execution and oversight.
- Build and maintain effective working relationships with investigator sites and internal stakeholders.
Minimum Qualifications- Bachelor's degree or higher in a healthcare or science-related field. (Alternate education levels may be considered based on experience and business need)
- 3 years of field-based CRA experience in the medical device and/or pharmaceutical industry.
- Strong understanding of clinical trial operations, monitoring practices, investigational product management, and data management.
- Thorough knowledge of domestic and international clinical research regulations, including ICH GCP, FDA CFR, ISO, and HIPAA.
Preferred Knowledge & Skills- Experience with IVD and/or POC studies.
- Laboratory experience in molecular biology, microbiology, or blood culture.
- Proficiency with Veeva Vault CTMS and CDMS
Primary Work LocationUSA MD - Sparks - 7 Loveton Circle
Additional LocationsWork ShiftNA (United States of America)
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Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
Salary Range Information 
