Senior Clinical Research Associate

Stellenbeschreibung:

Responsible for ensuring that study investigators and coordinators comply with the study protocol, Good Clinical Practices (GCPs), Code of Federal Regulations (CFRs), and Institutional Review Board (IRB)/Ethics Committee (EC) requirements during clinical studies by training/guidance of investigators/research coordinators, conducting periodic on-site evaluations and follow‑up of corrective actions
Acts as primary liaison to clinical sites.
Conducts site qualification visits, study start‑up activities (essential document collection), site qualification visits, site initiation visits and training, monitoring visits for source data verification (reported study data are accurate, complete, and verifiable from source documents in the site’s medical records), and site close‑out visits. Generates high‑quality site qualification, initiation, monitoring, and close‑out visit reports in timely manner (in accordance with the Clinical Monitoring Plan)
Contributes to protocol, informed consent, case report form (CRF) and study plan development as well as annual progress reports (APRs) and the clinical study report (CSR) at study conclusion to report the study results to FDA and other regulatory authorities
Ensures that the rights and well‑being of human subjects are protected and confirms data quality/integrity by maintaining site compliance, reviewing adverse events and device deficiencies, reviewing data trending/metrics, reviewing audit reports, and implementing corrective actions as necessary
Supports maintenance of department SOPs and work instructions
Supports investigational device traceability including documentation for forecasting, shipping, receipt, and disposition.
Supports and maintains documentation of all clinical research activities in the study trial master file (TMF), e.g., monitoring reports, site correspondence, device inventory information.
Drives trial enrollment and identifies and communications potential and actual obstacles to enrollment.

Requirements

Minimum of 5 years of directly related work experience or equivalent in clinical research, including work on medical device significant risk IDE trials and/or non‑significant risk abbreviated IDE trials.
Must be able to work autonomously and as a member of a cross‑functional team and meet high expectations and tight deadlines. May work on highly visible projects in high‑pressure situations
Must have working knowledge of Good Clinical Practices (GCPs), FDA regulations and IRB requirements.
Must have strong project management competencies and ability to work with high quality, reliability, and attention to detail.
Must have a strong level of professionalism, including verbal and written communication skills; and the ability to communicate with all levels of the organization, cross‑functionally, and with clients/partners.
Must have proficiency in using Microsoft Office Suite, including Word, Excel, Outlook and PowerPoint; as well as experience with electronic data capture (EDC) and electronic Trial Master File (eTMF) systems.
Experience interfacing successfully with physicians/clinical staff and familiarity with hospital/clinical environments
Familiarity with medical and anatomical terminology.
Ability and willingness to travel

Core Competencies

Demonstrates expertise in clinical research management, ensuring compliance with Good Clinical Practices (GCPs), FDA regulations, and IRB requirements. Proficient in project management, data integrity, and effective communication across cross‑functional teams.