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Regional Cancer Care Associates · 4 months ago

Regulatory Coordinator Assistant

Teaneck, NJ

Full-time

Onsite

Entry Level

$27.09/hr - $36.54/hr

1+ years exp

Regional Cancer Care Associates is seeking a dynamic Regulatory Coordinator Assistant to join their team. This role is essential for handling regulatory documents and applications necessary for launching new clinical trials, ensuring compliance with federal and local regulations, and maintaining comprehensive research files and documentation.

Health CareMedicalOncology

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

Qualification

GCPFDA regulationsClinical Trial Management SystemsERegulatory systemsElectronic Data CaptureMultitasking capabilitiesMS WordMS PowerPointMS ExcelMS TeamsZoomGoogle MeetAttention to detailCommunication skills

Required

High School Diploma required

A minimum of 1 year of experience in clinical trials, regulatory affairs, or an oncology-related field is required

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