Job Description
Innovate Health Solutions, a leader in groundbreaking medical research, is seeking a highly motivated and experienced Senior Clinical Research Coordinator to join our dynamic team in Boston, MA. This is an exceptional opportunity for a dedicated professional to play a pivotal role in advancing medical science through meticulous coordination and execution of complex clinical trials.
As a Senior CRC, you will be instrumental in managing all aspects of assigned clinical studies, ensuring strict adherence to protocols, regulatory guidelines (GCP, FDA), and ethical standards. We are looking for an individual with a passion for clinical research, excellent organizational skills, and a proven track record of successful trial management. If you are ready to make a significant impact in healthcare and contribute to life-changing discoveries, we invite you to apply.
Responsibilities
- Lead and manage all operational aspects of assigned clinical trials from startup to closeout.
- Ensure compliance with study protocols, Good Clinical Practice (GCP), FDA regulations, and institutional policies.
- Recruit, screen, and enroll eligible study participants, maintaining accurate documentation.
- Coordinate participant visits, tests, and procedures, ensuring data integrity and quality.
- Prepare and submit regulatory documents to IRBs/ECs and other relevant authorities.
- Monitor study budgets, expenditures, and manage financial aspects related to clinical trials.
- Serve as a primary liaison between investigators, sponsors, CROs, and study participants.
- Train and mentor junior research staff, promoting best practices and professional development.
Qualifications
- Bachelor's degree in a health-related field (e.g., Nursing, Biology, Public Health). Master's preferred.
- Minimum of 5 years of experience as a Clinical Research Coordinator, with at least 2 years in a senior or lead role.
- Strong understanding of clinical trial methodologies, GCP, and FDA regulations.
- Current certification as a Clinical Research Coordinator (e.g., CCRP, CCRC) is highly desirable.
- Demonstrated experience in managing multiple complex studies across various therapeutic areas.
- Proficiency with Electronic Data Capture (EDC) systems and clinical trial management systems (CTMS).
- Exceptional organizational skills, attention to detail, and ability to manage multiple priorities.
- Excellent communication, interpersonal, and leadership skills.