Job Description
Are you a highly motivated and experienced Clinical Research Coordinator ready to take the next step in your career? BioGenius Labs, a leading innovator in cutting-edge medical research, is seeking a Senior Clinical Research Coordinator to join our dynamic team in Boston, MA. We are at the forefront of developing groundbreaking therapies that transform patient lives.
At BioGenius Labs, you'll be more than just a coordinator; you'll be a vital part of a mission-driven organization, impacting the future of medicine. We offer a collaborative environment where your expertise is valued, your professional growth is encouraged, and your contributions directly accelerate the discovery of life-changing treatments. If you're passionate about clinical research excellence and eager to make a tangible difference, we invite you to explore this exciting opportunity.
Responsibilities
- Manage and oversee all aspects of complex clinical trials from initiation to close-out, ensuring adherence to protocols, GCP, and regulatory requirements.
- Coordinate participant recruitment, screening, enrollment, and retention efforts, maintaining accurate study logs and documentation.
- Serve as the primary point of contact for sponsors, CROs, IRBs, and study participants, fostering strong professional relationships.
- Conduct comprehensive data collection, entry, and quality control, resolving queries efficiently and accurately.
- Prepare and submit regulatory documents, amendments, and reports to relevant authorities and ethical committees.
- Train and mentor junior clinical research staff, promoting best practices and continuous improvement.
- Monitor study budgets and resources, ensuring efficient allocation and utilization.
- Participate in internal and external audits, ensuring clinical trial readiness and compliance.
Qualifications
- Bachelor's degree in a life science, nursing, or related health field. Master's degree preferred.
- Minimum of 4-5 years of progressively responsible experience in clinical research coordination, preferably in an academic or industry setting.
- Strong knowledge of ICH-GCP guidelines, FDA regulations, and human subject protection.
- Proven ability to manage multiple complex clinical trials simultaneously with exceptional organizational skills.
- Excellent written and verbal communication skills, with a track record of effective stakeholder engagement.
- Proficiency in electronic data capture (EDC) systems, clinical trial management systems (CTMS), and Microsoft Office Suite.
- Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) highly desirable.
- Demonstrated problem-solving abilities and a meticulous attention to detail.