Job Description
Are you ready to accelerate the development of life-changing therapies? Apex Therapeutics is seeking a highly skilled and dedicated Senior Clinical Research Associate to join our dynamic Clinical Operations team in Boston, MA.
In this pivotal role, you will oversee the clinical trial lifecycle, ensuring compliance with Good Clinical Practice (GCP) and regulatory standards while fostering strong relationships with investigators and site staff. We are looking for a visionary professional who thrives in a fast-paced environment and is committed to improving patient outcomes.
Why join Apex Therapeutics?
- Work on groundbreaking drug development programs.
- Competitive compensation and comprehensive benefits package.
- Access to cutting-edge training and career progression pathways.
- Collaborative culture that values innovation and integrity.
Responsibilities
- Oversee the initiation, implementation, and close-out of clinical trials at multiple sites.
- Ensure strict adherence to GCP guidelines, ICH, and regulatory requirements.
- Monitor data quality and integrity, resolving discrepancies and queries promptly.
- Maintain effective communication and collaboration with Clinical Investigators, study coordinators, and cross-functional teams.
- Conduct regular site visits to ensure trial conduct meets protocol specifications.
- Prepare and submit timely regulatory documents and reports.
Qualifications
- BS/BSN or PharmD degree in a relevant scientific discipline.
- Minimum of 3-5 years of experience as a Clinical Research Associate (CRA) in the pharmaceutical or biotechnology industry.
- Current GCP certification (e.g., RAC) is highly preferred.
- Strong understanding of regulatory submission processes (e.g., IND, NDA/BLA).
- Excellent written and verbal communication skills with a proven track record of stakeholder management.
- Ability to travel up to 50% as required by trial sites.