Job Description

A Senior Regulatory Compliance Coordinator position is currently available within the Tisch Cancer Center. The incumbent will work with investigators and the Cancer Clinical Trials Office (CCTO) infrastructure to manage cancer clinical trials for the division. Duties include, but are not limited to, management of clinical studies through the regulatory portion of the trial submission process, ensuring regulatory integrity of assigned clinical trials from approval to closure, develop new clinical trials and act as the main contact during the protocol development phase, correspond with the reviewing committees and personnel, assist in budget development by identifying research non-billables, and coordinate start-up meetings for new protocols.

The Senior Regulatory Compliance Coordinator will act as a mentor to junior staff- providing oversight and training to multiple study teams who develop and submit documentation and information for Institutional Review Board (IRB) review and who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies. The Senior Regulatory Compliance Coordinator is a resource for Investigators and Research Teams The position will report into the Assistant Director of Regulatory Compliance.

Individuals should be comfortable with working in a team environment and will be expected to work collaboratively with investigators and administration. Cancer protocols include industry-sponsored, consortium, NCI projects, and investigator-initiated studies.

Responsibilities

• Protocol development: Assist multi-disciplinary group of hematology/oncology Principal Invetigators and researchers with development of investigator-initiated clinical trial protocols. Must understand complex scientific terminology and local, state, and federal regulatory requirements. Create informed consent forms, case report forms, and additional study documents, as needed per protocol.
• Develops and/or revises regulatory standard operating policies and procedures.
• Submits protocol applications for IRB review in a timely manner; tracks new protocols through the internal study start-up committee system to approval and activation, including responding to committees' inquiries for clarification.
• Gathers clinical and safety data needed to prepare and process applications for IRB annual renewal review and approval.
• Collaborates with the Principal Investigator (PI) in completion of required regulatory documents including, but not limited to: Conflict of Interest forms, delegation of authority logs, legal agreements, investigational pharmacy forms, serious adverse event forms, etc.
• Collaborates with the Clinical Trials Manager in developing and ensuring clinical trial regulatory compliance.
• Coordinates communication with investigators and members of the research team to aid in study development and oversight throughout the life-cycle of clinical trial.
• Participate in Clinical Trial Feasibility, Site Selection Process, and the Site Initiation Visit, which includes conducting interviews with scientists, doctors and academics and others in a network of industry experts.
• Submits Investigational New Drug (IND) Applications and obtains approval from the Food and Drug Administration (FDA) for investigator-initiated clinical trials. Acts as primary contact for all FDA communication, including submission of serious adverse events, amendments, annual reports, and other submissions as required.
• Collaborates with the Financial Manager on the development of the study budget (as needed); identifies billable versus research non-billable procedures.
• Updates and maintains records of clinical trial status on clinicaltrials.gov website as mandated by FDA and National Institutes of Health (NIH). Analyzes moderate to complex clinical research data related to oncology, immunology, microbiology, etc; Assists in interpreting clinical research data used in scientific publication. Must have strong science background.
• Coordinates research team communication, including: notification of clinical trial activation, enrollment closures, protocol amendments, and final study closures. Distributes regulatory documents throughout the life-cycle of clinical trial.,
• Ensures proper regulatory compliance in accordance with sponsoring agency requirements. Maintains study specific regulatory binder(s).
• Works with auditors and auditory committees to assess trial compliance and related issues.
• Able to read and understand scientific pre-clinical and clinical data applied to the conduct of clinical trials.
• Acts as liaison between research team and sponsor for important clinical trial notices, updates, and monitoring visits. Mentors and trains less experienced research staff including Clinical Research Coordinators and Data Analysts.
• Participates in development of SOPs and ensures compliance within disease teams.
• Assists development of CCTO training activities
• Provides mentorship and training to junior regulatory compliance coordinators.
• Performs other related duties as assigned.

Qualifications

• Bachelors Degree (Masters preferred) ideally in science or health care policy.
• 5+ years preferred of direct experience in Regulatory Affairs, Clinical Affairs or Quality Assurance within the Medical Device Industry.
• Preferred:
  • Working knowledge of Good Clinical Practice guidelines and Code of Federal regulations.
  • Oncology experience; some medical knowledge preferred.
  • Certification Preferred in one of the following: SoCRA, ACRP, or RAPS
  • Excellent written and oral communication skills
  • Ability to foster smooth communications and teamwork among clinical research faculty, fellows and staff as well as external sites and organizations (sponsors and contract research organizations).
  • Analytical skills for problem solving; attention to detail and accuracy.
  • Demonstrate strong organizational skills; ability to manage multiple tasks & priorities.
  • Solid experience in using MC Office programs and software including Word, Excel, PowerPoint, and Outlook