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Clinical Research Coordinator

2 months ago

New York, United States Brooklyn Clinical Research Full time

Clinical Research Coordinator

Location: Brooklyn, NY


Company history: 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.


This position is for our flagship location in Brooklyn, NY. As an early-stage employee, you will have the opportunity to grow with the company and help shape the organization and its values. Your input will be valued, and there will be meaningful opportunities for professional development.


The Clinical Research Coordinator (“CRC”) monitors data management and regulatory aspects of clinical-trial operations and will ensure that research is conducted in accordance with the sponsor’s protocol, FDA Regulations, and ICH/GCP guidelines. The CRC 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 CRC should be a detailed-oriented, self-motivated professional with a track record of successfully adhering to clinical-trial protocols and exceeding sponsor expectations.


Our primary therapeutic areas are infectious diseases and cardiovascular, obesity, and related endocrine conditions.


Estimated Start Date: August 19th, 2024


DUTIES & 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, eSource, eRegulatory, and our internal database.

•        Working effectively with sponsor specified IVRS and EDC systems.

•        Conducting and overseeing study participant visits, and all other relevant protocol-required procedures -- including blood draws -- 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 and implementation 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, organizational SOPs, and assigned study protocol(s).

•        Maintaining a working knowledge of the recruitment and retention processes for the assigned protocol(s).

•        Preparing for Sponsor and CRO visits for the respective protocol(s).

•        Maintaining a comprehensive 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.

•        Managing study participants’ scheduling, visit tracking, stipends, and transportation.

•        Maintaining a comprehensive 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.

•        Work supplementally with our recruitment team to pre-screen and schedule study participants.


KNOWLEDGE & EXPERIENCE

Education:

•        Bachelor's degree in health or science-related major preferred

•        ICH-GCP Certification and IATA Certification

•        Phlebotomy Certification


Experience:

•        1-2 years’ experience in clinical research, preferably as a CRC.

•        Wide therapeutic range of clinical-trial experience preferred.

•        Regulatory research experience is a plus.

•        Experience as a Medical Assistant or similar role is a plus.


Credentials:

•        ACRP or equivalent certification 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.