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Principal Clinical Research Associate
Other Jobs
#31864
Remote / WFH
BD
Job Description
Job Description
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.
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.
