Job Description
Join the forefront of medical innovation as a Senior Clinical Research Associate (CRA) at Apex Clinical Solutions.
We are a leader in biopharmaceutical research, dedicated to bringing life-changing therapies to patients worldwide. We are currently seeking a highly motivated, detail-oriented professional to join our dynamic clinical operations team in Boston.
In this role, you will serve as the primary liaison between our study teams and clinical investigators, ensuring the integrity of clinical data and adherence to regulatory standards. You will have the opportunity to work on groundbreaking Phase II-IV trials and contribute to the advancement of modern medicine.
Why Join Us?
- Competitive Compensation: Base salary range of $95k - $135k with annual performance bonuses.
- Comprehensive Benefits: Premium health, dental, and vision insurance, 401(k) matching, and flexible PTO.
- Professional Growth: Access to top-tier training, GCP certifications, and clear pathways to management.
Ready to advance your career in clinical research? Apply today to become a vital part of our mission.
Responsibilities
- Initiate, monitor, and close out clinical trials in strict accordance with Good Clinical Practice (GCP) and regulatory requirements.
- Conduct routine site visits to verify patient safety, protocol compliance, and data integrity.
- Manage study budgets and timelines, ensuring projects stay on track and within financial constraints.
- Communicate effectively with investigators, study coordinators, and internal cross-functional teams.
- Monitor source documents and ensure accurate data entry into electronic data capture (EDC) systems.
- Prepare and submit regulatory correspondence, amendments, and reports to the FDA and ICH guidelines.
- Identify and mitigate study risks to ensure successful trial outcomes.
Qualifications
- Bachelor’s degree in Nursing, Pharmacy, Life Sciences, or a related field required; Master’s degree or PharmD preferred.
- Current GCP certification (e.g., CCRC) is mandatory.
- Minimum of 3-5 years of clinical research experience in the pharmaceutical or biotechnology industry.
- Strong working knowledge of regulatory guidelines (FDA 21 CFR Part 11, ICH GCP E6).
- Excellent interpersonal and communication skills with the ability to build rapport with clinical investigators.
- Proficiency in Microsoft Office Suite and EDC systems (e.g., REDCap, Medidata Rave).
- Willingness to travel up to 50% of the time to various clinical sites.