Please note this is a remote role, we will be considering roles from around the United States.
Objective
The Senior Clinical Research Associate is responsible for managing and monitoring clinical studies from start-up through closeout, ensuring compliance with study protocols, GCP, ICH guidelines, FDA regulations, and applicable global requirements. This role partners with sites, CROs, and cross-functional teams to support patient safety, data quality, regulatory compliance, and successful study execution.
Responsibilities
- Coordinate and oversee clinical trial activities from study start-up through closeout.
- Conduct remote and on-site monitoring visits, including qualification, initiation, routine monitoring, and closeout visits.
- Ensure protocol compliance, data accuracy, source document verification, and overall study quality.
- Maintain study documentation, TMF/eTMF files, and inspection-ready records.
- Support safety reporting activities, including adverse events (AEs), serious adverse events (SAEs), and follow-up actions.
- Collaborate with investigative sites, CROs, vendors, and internal stakeholders to ensure successful study execution.
- Assist with regulatory submissions, FDA reporting, ClinicalTrials.gov updates, and post-market clinical activities.
- Support audits, inspections, and quality initiatives while ensuring ongoing regulatory compliance.
- Contribute to process improvements, SOP development, and clinical operations best practices.
Requirements
- Bachelor's degree in Life Sciences, Health Sciences, Nursing, Pharmacy, or a related field (Master's degree preferred).
- 4+ years of clinical research experience within the medical device, pharmaceutical, CRO, or healthcare industry (Class III medical device experience preferred).
- Strong knowledge of GCP, ICH guidelines, FDA regulations, and clinical trial processes (RAPS, CCRP, or similar certification preferred).
- Experience conducting site monitoring visits, source data verification, and managing study documentation (multi-site and international study experience preferred).
- Proficiency with Microsoft Office applications (experience with CTMS, eTMF, and EDC systems preferred).
- Strong organizational, problem-solving, and communication skills with the ability to manage multiple priorities independently (audit and inspection support experience preferred).
- Ability and willingness to travel domestically and internationally as needed
Important Note: This job description includes the necessary aspects required to evaluate this job position. It should not be used as a comprehensive list
of all responsibilities, skills or functions.
