Responsibilities

Study & Site Management

• Serve as Lead CRA for assigned complex clinical studies, providing expert oversight of site selection, initiation, monitoring, and close‑out activities (on‑site, virtual, remote, and in‑house).

• Actively participate in site feasibility assessments and site selection processes.

• Ensure study conduct is executed according to the clinical protocol (CPSP), 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 strict 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.

• Support interviewing, hiring, onboarding, and training of CRA staff.

• Manage and oversee day‑to‑day activities of contingent CRAs, including approval of timecards and expense reports.

• 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, CROs, and SMOs to ensure high‑quality study execution and oversight.

• Build and maintain effective working relationships with investigator sites and internal stakeholders.

Qualifications

Education

• Bachelor’s degree or higher in a healthcare or science‑related field.

• Alternate education levels may be considered based on experience and business need.

Experience

• Minimum of five (5) years of field‑based CRA experience in the medical device and/or pharmaceutical industry.

• Experience across multiple phases of clinical research and product development.

• Experience with IVD and/or POC studies strongly preferred.

• Laboratory experience in molecular biology, microbiology, or blood culture is highly desirable.

Knowledge & Skills

• 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.

• Proficiency with Veeva Vault CTMS and CDMS required.

• Excellent written and verbal English communication skills, including medical terminology.

• Strong presentation, organizational, time‑management, and prioritization skills.

• Technically savvy with the ability to leverage technology to drive efficiency and performance.

• Ability to work independently with minimal supervision in a fast‑paced environment.