Job Description
Shape the Future of Medicine
Apex Health Solutions is a premier biopharmaceutical company dedicated to accelerating the development of life-saving therapies. We are currently seeking a Senior Clinical Research Associate (S-CRA) to join our dynamic Clinical Operations team. In this pivotal role, you will ensure the integrity of our clinical data and the safety of our trial participants across multiple sites.
We pride ourselves on a culture of innovation, transparency, and mutual respect. As an S-CRA, you will work closely with principal investigators, study managers, and cross-functional teams to deliver high-quality clinical trials.
Why Join Us?
- Competitive salary and comprehensive benefits package.
- Flexible hybrid work schedule.
- Professional development and certification reimbursement.
- State-of-the-art lab facilities and resources.
Responsibilities
- Monitor the operational and clinical conduct of assigned clinical trials in accordance with the protocol, GCP, and regulatory requirements.
- Conduct on-site monitoring visits to assess site readiness, investigator performance, and data quality.
- Manage and maintain positive relationships with key investigators, site staff, and study coordinators.
- Review source documents and Case Report Forms (CRFs) for accuracy, completeness, and compliance before finalization.
- Identify, document, and mitigate trial risks and deviations in a timely manner.
- Prepare and submit accurate regulatory reports and clinical study reports.
Qualifications
- Bachelor’s degree in Nursing, Life Sciences, Pharmacy, or a related field required; Master’s degree preferred.
- Minimum of 3-5 years of experience as a Clinical Research Associate or equivalent clinical setting experience.
- Current certification in Good Clinical Practice (GCP) is mandatory.
- Proven experience with electronic data capture (EDC) systems (e.g., REDCap, Oracle Clinical) and eTMF.
- Strong analytical skills with exceptional attention to detail and organizational abilities.
- Valid driver’s license and willingness to travel up to 50% of the time to various study sites.