Research Coordinator

Circuit Clinical•Secaucus, NJ

2d•Onsite

About The Position

Circuit Clinical is hiring a full-time Research Coordinator to coordinate, facilitate, and monitor research study protocols in accordance with departmental and institutional policies, sponsor requirements, and FDA regulations. The role also provides, manages, and coordinates care for patients participating in clinical trials in compliance with written study protocols. The Research Coordinator reports to the VP, Site Operations and collaborates with the Clinical Operations, Regulatory, and Business Development teams. This is an on-site position based primarily in Secaucus, New Jersey, with travel to sites within a 25-mile radius. The position is full-time and exempt.

Requirements

Current license or certification as a registered nurse (RN), certified Medical Assistant, or licensed practical nurse (LPN).
At least 1–3 years of experience in clinical research.
Reliable transportation.
Computer literacy, including Microsoft Office (Word and Excel) and Google Suite.

Nice To Haves

Bachelor’s degree preferred.
Experience with CTMS software is a plus.

Responsibilities

Maintain thorough knowledge of study protocols, inclusion and exclusion criteria, and subject eligibility requirements.
Understand study endpoints, reportable events—including Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest—the disease process, and standard of care.
Complete study screening tools and study summaries.
Define methods for subject identification and recruitment.
Conduct the Informed Consent Form process in accordance with study protocols.
Complete screening procedures, randomization, and subject visits.
Dispense and maintain accountability for investigational products.
Schedule study visits in compliance with protocols.
Prepare and maintain source documents and IRB-submitted recruitment documents.
Assist with recruitment by contacting and identifying potentially eligible participants for screening.
Confirm Primary Investigator review of study visits.
Review Adverse Events and Serious Adverse Events with the Primary Investigator within 24 hours of the event report to the IRB and sponsor.
Carry out subject retention activities and follow-up procedures.
Obtain consents for amendments where applicable.
Participate in protocol amendment training and update essential documents accordingly.
Support sponsor monitoring activities, preparation, and data clarification.
Review study status weekly.
Obtain appropriate certification for required trainings.
Contribute to patient recruitment efforts as business demands require.
Perform additional duties as assigned.