Job Description
Are you a seasoned Clinical Research Coordinator ready to take on a leadership role in groundbreaking medical science? Vertex BioLabs, a pioneering institution at the forefront of clinical innovation, is seeking a highly motivated and experienced Lead Clinical Research Coordinator to join our dynamic team in Boston, MA. This is an unparalleled opportunity to steer pivotal research studies, directly impacting patient outcomes and contributing to the future of medicine.
At Vertex BioLabs, we are committed to pushing the boundaries of scientific discovery. Our state-of-the-art facilities and collaborative environment foster an atmosphere where your expertise will thrive. As a Lead CRC, you will be instrumental in ensuring the highest standards of research integrity, regulatory compliance, and patient care across multiple clinical trials. If you are passionate about advancing healthcare and possess a meticulous eye for detail, we invite you to apply and become a vital part of our mission.
Responsibilities
- Lead and manage the execution of complex clinical trials from initiation to close-out, ensuring adherence to study protocols, ICH-GCP guidelines, and regulatory requirements.
- Oversee patient recruitment, screening, consent, and retention processes, ensuring ethical considerations and study timelines are met.
- Coordinate and manage all aspects of data collection, source documentation, case report forms (CRFs), and electronic data capture (EDC) systems, ensuring data quality and integrity.
- Serve as a primary liaison between investigators, sponsors, Institutional Review Boards (IRBs), and other internal/external stakeholders.
- Develop and maintain comprehensive study documentation, including regulatory binders, site master files, and essential documents.
- Provide mentorship and guidance to junior research staff, fostering a collaborative and high-performing team environment.
- Participate in site visits, audits, and inspections, ensuring readiness and successful outcomes.
- Manage study budgets, timelines, and resource allocation to ensure efficient trial execution.
Qualifications
- Bachelor's degree in a health-related field (e.g., Nursing, Life Sciences, Public Health); Master's degree preferred.
- Minimum of 5 years of experience as a Clinical Research Coordinator, with at least 2 years in a lead or senior capacity.
- Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification highly desirable.
- Demonstrated in-depth knowledge of ICH-GCP guidelines, FDA regulations, and ethical principles of human subjects research.
- Proficiency in electronic data capture (EDC) systems, clinical trial management systems (CTMS), and Microsoft Office Suite.
- Exceptional organizational skills, meticulous attention to detail, and ability to manage multiple complex projects concurrently.
- Strong interpersonal, communication (written and verbal), and leadership skills, with the ability to effectively collaborate with diverse teams.
- Proven problem-solving abilities and a proactive approach to addressing research challenges.