Senior Clinical Research Associate

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Accountable for ensuring that study investigators and coordinators adhere to the study protocol, Good Clinical Practices (GCPs), Code of Federal Regulations (CFRs), and Institutional Review Board (IRB)/Ethics Committee (EC) requirements throughout clinical studies by providing training and guidance to investigators and research coordinators, conducting regular on-site evaluations, and following up on corrective actions.

• Serves as the primary point of contact for clinical sites.

• Executes site qualification visits, initiates study start-up activities (essential document collection), conducts site initiation visits and training, performs monitoring visits for source data verification (ensuring reported study data is accurate, complete, and can be verified from source documents in the site’s medical records), and carries out site close-out visits. Produces high-quality site qualification, initiation, monitoring, and close-out visit reports promptly (in line with the Clinical Monitoring Plan).

• Contributes to the development of protocols, informed consent forms, case report forms (CRFs), and study plans, as well as annual progress reports (APRs) and the clinical study report (CSR) upon study completion to communicate results to the FDA and other regulatory bodies.

• Safeguards the rights and well-being of human subjects, ensuring data quality and integrity by maintaining site compliance, reviewing adverse events and device deficiencies, analyzing data trends/metrics, assessing audit reports, and implementing corrective actions as needed.

• Aids in the upkeep of departmental SOPs and work instructions.

• Assists in the traceability of investigational devices, which includes documentation for forecasting, shipping, receipt, and disposition.

• Maintains comprehensive documentation of all clinical research activities in the study trial master file (TMF), including monitoring reports, site correspondence, and device inventory information.

• Promotes trial enrollment and identifies and communicates potential as well as actual barriers to enrollment.

⛳️ Requirements

• A minimum of 5 years of relevant work experience or equivalent in clinical research, specifically involving medical device significant risk IDE trials and/or non-significant risk abbreviated IDE trials.

• Ability to work independently and as part of a cross-functional team, meeting high expectations and tight deadlines. May be involved in highly visible projects in high-pressure environments.

• Comprehensive working knowledge of Good Clinical Practices (GCPs), FDA regulations, and IRB requirements.

• Strong project management skills with the capability to deliver high-quality work with reliability and meticulous attention to detail.

• High level of professionalism, including exceptional verbal and written communication skills, and the ability to engage with all levels of the organization, cross-functionally, and with clients and partners.

• Proficiency in Microsoft Office Suite, including Word, Excel, Outlook, and PowerPoint, along with experience using electronic data capture (EDC) and electronic Trial Master File (eTMF) systems.

• Experience successfully interfacing with physicians and clinical staff, with familiarity in hospital and clinical environments.

• Understanding of medical and anatomical terminology.

• Willingness and ability to travel.

🏝️ Benefits

• Travel requirement: 25-50%