Clinical Research Coordinator
Location: Brooklyn, NY
About Brooklyn Clinical Research:
Brooklyn Clinical Research was founded to increase access to clinical trials for underrepresented populations. Clinical-trial enrollment should accurately represent the broader population. In meeting this objective, we help improve therapeutic efficacy and safety for all individuals.
The Senior Clinical Research Coordinator (“SCRC”) monitors all data management, regulatory and financial aspects of clinical-trial operations and ensures that research is conducted in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines. The SCRC will also ensure that the data provided to the sponsor are of the highest quality and that study enrollment meets or exceeds the sponsor’s expectations. As such, the SCRC should be a detailed-oriented, experienced coordinator with a track record of successfully adhering to clinical-trial protocols and exceeding sponsor expectations.
Responsibilities
• Completing all relevant training prior to study start and all additional protocol-amendment trainings.
• Adherence to ALCOA-C Standards with all clinical trial documentation.
• Working effectively with EDC, CTMS, eISF, and HubSpot.
• Working effectively with sponsor specified IVRS, EDC, eDiary, ePayment, and additional study related systems.
• Conducting and overseeing study participant visits, and all other relevant protocol-required procedures while documenting relevant data in a timely, accurate manner.
• Completing and overseeing data entry and query resolution in a timely manner as per company guidelines and sponsor expectations.
• Demonstrated understanding, implementation and supervision of protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory for assigned protocols.
• Liaising with the administrative staff, clinical investigators, research participants and Sponsor/CRO representatives for assigned protocols.
• Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s).
• Training and mentoring junior staff.
• Preparing for monitoring visits for their respective protocol(s).
• Maintaining a working knowledge of the most recent versions of the Study Protocols, Informed Consents, Study Manuals, and all the other relevant study-related documents that are utilized for the assigned protocols.
• Maintaining a working knowledge of study participants’ scheduling, visit tracking, stipends, and transportation by liaising with our administrative staff.
• Maintaining a working knowledge of all essential clinical trial documents and maintenance of the Investigator Site Binders for their assigned protocol(s).
• Work with the Principal Investigator(s) on the reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per Sponsor, IRB, and ICH-GCP Guidelines.
• Traveling to industry conferences and meetings when necessary.
Qualifications
Education:
• Bachelor's degree in health or science-related major preferred.
• ICH-GCP Certification and IATA Certification.
Experience:
• 3+ years’ experience in clinical research.
• Supervisory experience preferred.
• Wide therapeutic range of clinical-trials experience preferred.
• Regulatory experience is a plus.
Knowledge and Skills:
• Goals-driven while continuously maintaining quality.
• Must be a detail-oriented and proactive self-starter.
• Must have strong written and verbal communication skills.
• Must have excellent customer service skills.
• Bilingual in Spanish is a plus but is not required.
Starting Salary Range: $87,500 - $95,000
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