Job Description
Beacon BioResearch is a leading innovator in clinical trials, dedicated to advancing medical science and improving patient outcomes. We are seeking a highly motivated and experienced Senior Clinical Research Coordinator to join our dynamic team in Boston, MA. This pivotal role involves managing complex clinical trials from initiation to close-out, ensuring compliance with protocols, regulatory requirements, and ICH-GCP guidelines. If you are passionate about healthcare, meticulous in your work, and thrive in a collaborative environment, this is your opportunity to make a significant impact.
As a Senior Clinical Research Coordinator, you will be instrumental in the successful execution of groundbreaking studies that can change lives. You will serve as the primary point of contact for sponsors, investigators, and study participants, facilitating seamless communication and efficient trial progress. We offer a challenging yet rewarding career path with ample opportunities for professional growth and development in a state-of-the-art facility.
Responsibilities
- Coordinate and manage all aspects of clinical trials, ensuring adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP).
- Oversee participant recruitment, screening, consent, enrollment, and retention efforts.
- Prepare and submit regulatory documents to IRBs, sponsors, and other relevant authorities.
- Maintain accurate and comprehensive study documentation, including source documents, case report forms (CRFs), and electronic data capture (EDC) systems.
- Administer study medications, perform vital signs, collect biological samples, and conduct patient assessments as per protocol.
- Serve as the primary liaison between investigators, sponsors, and study participants, facilitating effective communication.
- Monitor study budgets, track expenditures, and ensure efficient use of resources.
- Assist in preparing for and participating in sponsor monitoring visits and regulatory audits.
Qualifications
- Bachelor's degree in Nursing, Life Sciences, Healthcare Administration, or a related field.
- Minimum of 4-5 years of direct experience as a Clinical Research Coordinator, preferably in a hospital or academic setting.
- Strong knowledge of ICH-GCP guidelines, FDA regulations, and ethical considerations in human research.
- Proficiency with Electronic Data Capture (EDC) systems and clinical trial management software.
- Excellent organizational skills with meticulous attention to detail and the ability to manage multiple projects simultaneously.
- Exceptional communication (written and verbal) and interpersonal skills.
- Certification as a Clinical Research Coordinator (e.g., CCRP, CCRC) is highly preferred.
- Ability to work independently and collaboratively in a fast-paced research environment.