Regulatory Coordinator Assistant
RCCA MSO LLC·Teaneck, New Jersey
RCCA MSO LLC·Teaneck, New Jersey
The Regulatory Coordinator Assistant is responsible for preparing, compiling, and submitting regulatory documents for clinical trials while ensuring compliance with FDA and IRB regulations. They also manage site documentation, coordinate monitoring visits, and address inquiries from sponsors and clinical trial teams.
Description RCCA is seeking a dynamic Regulatory Coordinator Assistant to join our team!
This vital role is responsible for handling all regulatory documents and applications essential for launching new clinical trials.
As our Regulatory Coordinator Associate, you will submit continuations and amendments, address inquiries, generate detailed reports, and maintain comprehensive research files and documentation to ensure compliance with regulatory requirements for studies and clinical trials.
You'll play a key role in ensuring adherence to all federal and local regulations, including those set forth by the Food and Drug Administration (FDA) and the local Institutional Review Board (IRB).
Additionally, you'll represent RCCA in meetings with pharmaceutical companies, actively participate in team meetings, and collaborate with fellow staff members to ensure all regulatory documents and requirements are consistently met and updated.
Join us in making a meaningful impact in clinical research and compliance, while fostering strong relationships with industry partners!
As of the date of this posting, RCCA offers a comprehensive benefits package for this position, subject to eligibility requirements. In addition to the salary, we provide: Health, dental, and vision plans, Wellness program, Health savings account - Flexible spending accounts, 401(k) retirement plan, Life insurance, Short-term disability insurance, Long-term disability insurance, Employee Assistance Program (EAP), Paid Time Off (PTO) and holiday pay, Tuition discounts with numerous universities.
We believe these benefits underscore our commitment to the well-being and professional growth of our employees.
Prepare, compile, update, and submit regulatory documents from start to finish. This includes the study feasibility questionnaire, start-up application, Investigator Brochures, Protocol/Amendments, Informed Consent Form/Amendments, IRB start-up/renewal/termination, SAE Report, Protocol Deviations, and SUSARs to the Sponsor, IRBs and other regulatory bodies. Address all inquiries from the RCCA clinical trial team, Sponsor, IRBs and other regulatory bodies related to the study's regulatory aspects. Complete forms and generate all necessary reports to ensure compliance with regulatory requirements and RCCA institutional policies. Establish and maintain electronic and paper documentation, including Investigator Site Files (ISF)/regulatory binders, and other documentation relevant to regulatory requirements for clinical trials. Schedule and coordinate site initiation visits, interim monitoring visits, and close-out visits with the Sponsor and the RCCA clinical trial team. Generate the necessary regulatory documentation for study start-up, site initiation visits, routine monitoring visits, and close-out visits. Maintenance of Monitor Tracking Log. Collect, track, and maintain all regulatory documents, including Delegation of Authority (DOA) Logs, Training Logs (GCP, CV, IATA), medical licenses, malpractice insurance, lab licenses, pharmacy licenses, protocols, ICF, Investigator’s Brochure (IB), Pharmacy Manual, Lab Manual, Radiology Manual, Temperature Logs, DARF, Study Kits Log, and Calibration Logs, ensuring that all documents for the research studies are compliance with ICH-GCP, FDA Compliance. Periodically review Source Documents, Case Report Forms (CRFs), Study Documents, Logs, and Master Files with coordinators and staff to ensure quality, completeness, and accuracy. Issue queries for all reviewed documentation and investigate any systemic issues and report feedback to clinical trial management. Review monitor follow-up letters and ensure that any outstanding issues are addressed. Participate in required clinical trial meetings, training sessions, and educational huddles. Responsible for in-house and offsite archiving and retention of regulatory documentation, ensuring that everything is organized and easily accessible.
High School Diploma required; Associate degree preferred. A minimum of 1 year of experience in clinical trials, regulatory affairs, or an oncology-related field is required.
A significant portion of the work involves computer-based tasks. The physical demands outlined here represent those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made for individuals with disabilities. The job requires standing and walking for extended periods and occasionally lifting and carrying items weighing up to 40 lbs. Employees must have corrected vision and hearing within a normal range.
Market context
In New Jersey, administration roles in healthcare often draw steady demand because offices need staff who can manage insurance communication, documentation, and day-to-day coordination. These positions are competitive when candidates bring computer literacy, comfort speaking with insurers, and prior medical reimbursement experience; the listed requirements and benefits here are AI-summarized from the original job description, which can save you research time. Before applying, review whether your experience with reimbursement workflows and patient-facing or insurer-facing communication matches the posting.
