Job Description
Are you ready to shape the future of patient care? Apex Medical Innovations is seeking a highly skilled Senior Clinical Research Associate (S-CRA) to lead our dynamic clinical operations team in New York.
In this pivotal role, you will bridge the gap between pharmaceutical sponsors and clinical trial sites, ensuring the integrity of data and the safety of trial participants. We are looking for a leader who thrives in a fast-paced environment and is passionate about accelerating medical breakthroughs.
Why Join Us?
- Competitive Compensation: Base salary $95k-$135k plus performance bonuses.
- Comprehensive Benefits: Premium health, dental, and vision coverage.
- Career Growth: Clear pathways to Clinical Project Management and Operations leadership.
Don't just watch progress happen—be the engine driving it. Apply today to join a team that values excellence and innovation.
Responsibilities
- Oversee the initiation, execution, and close-out of clinical trials in accordance with Good Clinical Practice (GCP) and regulatory requirements.
- Monitor site activities remotely and on-site to ensure data integrity, protocol adherence, and patient safety.
- Conduct regular site visits, perform source document verification, and manage site initiation and monitoring meetings.
- Communicate effectively with investigators, study coordinators, and sponsor representatives to resolve clinical and operational issues.
- Prepare and submit comprehensive monitoring reports and deviation reports to the Sponsor.
- Manage timelines and budgets for assigned trials, ensuring milestones are met efficiently.
- Mentor junior CRAs and contribute to the development of site selection and monitoring strategies.
Qualifications
- Minimum of 3 years of clinical research experience, preferably in a pharmaceutical or CRO setting.
- Current RN, PharmD, or MSN degree preferred; Bachelor's degree with significant experience may be considered.
- Certified Clinical Research Professional (CCRP) or GCP certification required.
- Strong understanding of FDA 21 CFR Part 11 and ICH-GCP guidelines.
- Excellent verbal and written communication skills with the ability to present complex data clearly.
- Proficiency in electronic data capture (EDC) systems and Microsoft Office Suite.
- Ability to travel up to 50% of the time to various clinical sites.