RCCA MSO LLC
Location
Teaneck, New Jersey
Salary
$27 - $37 / HOUR
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.
Candidates must have at least a high school diploma, with an associate degree preferred, and a minimum of one year of experience in clinical trials or regulatory affairs. Proficiency in regulatory standards like GCP and ICH, along with experience in clinical trial software, is required.
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.