Regulatory Coordinator Assistant

Regulatory Coordinator Assistant

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!

Employment Type: Full Time

Location: Teaneck, NJ

Compensation: $27.09 - $36.54 per hour

Compensation packages based on your unique skills, experience, and qualifications

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.

Essential Duties and Responsibilities:

• 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.

Requirements:

• 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.

Specialized Knowledge/Skills:

• Knowledge of GCP, ICH, FDA, and EMA regulations.
• Strong familiarity with eRegulatory systems, Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), OncoEMR, MS Word, PowerPoint, Excel, PDF, internet applications, MS Teams, Zoom, and Google Meet.
• Ability to work in a fast-paced environment with a high level of attention to detail, strong multitasking capabilities, and excellent communication skills.

Working Conditions:

The position is typically based in a traditional outpatient clinic or office environment. Monday to Friday from 8am to 5pm. Ability to travel within RCCA network when required.

The working conditions described are representative of those an employee may encounter while fulfilling the essential functions of the job. Reasonable accommodation may be made for individuals with disabilities.

Employees may be exposed to communicable diseases, toxic substances, ionizing radiation, medical preparations, and other conditions common to an oncology/hematology clinic environment.

Physical Requirements:

• 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.