Description

Job Summary

The Research Regulatory Coordinator (RRC) supports the clinical research efforts of Nicklaus Children's Research Institute (NCRI) by providing comprehensive regulatory management of clinical trials in accordance with human subject federal regulations and internal standard operating procedures (SOPs). Responsibilities related to regulatory coordination activities include independently managing and preparing submissions of new studies, modifications, renewals, adverse events, and study closures to the Institutional Review Board (IRB) and other ancillary committees. In addition, the RRC serves as the liaison to sponsors, governing agencies and facilitates transmission of verbal and written communication to National Clinical Trials Network (NCTN) groups, pharmaceutical companies, and other research entities as needed. Also responsible for maintaining communication with all elements of a multi-level research network, including interacting with sponsoring agencies including National Cancer Institute, and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors.

Job Specific Duties

• Independently creates and prepares all aspects of regulatory protocol submissions while closely adhering to committee deadlines and review dates. This includes preparing new studies, modifications, renewals, final closure applications, and creating consent documents.
• Regularly communicates with internal committee administrators, investigators, research personnel, and study sponsors. Serves as the subject-matter-expert for the assigned research portfolio regarding protocol submission and regulatory status.
• Ensures compliance with federal, state, NCRI and hospital regulations and policies for the assigned research portfolio.
• Manages and coordinates the regulatory study information among investigators, research personnel, nurses, and pharmacy staff to achieve resolution for any concerns that may arise during the study.
• Reviews National Clinical Trials Network (NCTN) website regularly for protocol updates and changes, implementing and submitting them to the IRB.
• Coordinates protocol site activation with Sponsors and all other research personnel.
• Maintains close collaboration with the Clinical Trials Office (CTO) to support protocol compliance with regulatory agencies.
• Liaises with the Office of Sponsored Projects to ensure timely budget execution, budget re-negotiation, and provides input to troubleshoot sponsor financial delinquencies and study document alignment.
• Meets and prepares information to sponsors and internal quality monitors for the review of regulatory and protocol documents.
• Prepares and maintains electronic regulatory binder.
• Prepares, submits, and maintains all regulatory documents within the regulatory electronic binders (i.e., FDA 1572, Financial Disclosures, Delegation of Duties Log, Protocol and IB signature pages, CVs, Medical Licenses, Lab License, etc.) according to sponsor requirements and FDA regulations for the assigned research portfolio.
• Prepares, submits, and maintains FDA IND submissions for investigator-initiated trials and compassionate/emergency use requests according to FDA regulations.
• Participates in internal audit reviews of studies undergoing audits by sponsors, NCTN, and the FDA to ensure the highest level of compliance is maintained and minimizes audit findings.
• Inputs information in the clinical trials management system, guaranteeing all aspects of protocol information are input accurately.
• Maintains accurate work assignment lists and provide status updates for the assigned research portfolio and work progress identifying potential delays, problematic areas while maintaining adherence to required timelines.
• Collaborates with CTO for submissions to the IRB regarding timely reporting of adverse events, protocol violations and deviations to the IRB or other agency as required to ensure the health, safety, and welfare of the research participant.
• Provides and maintains regular updates to NCI's Clinical Trials Reporting Program for information on accrual for all Nicklaus authored NCI funded clinical trials.
• Registers and maintains regular updates to clinicaltrials.gov reporting for information on accrual and submit summary results on all clinical trials.
• Ensures accuracy to the different reporting programs and resolves any discrepancies as needed with each reporting programs.
  
  

Qualifications

Minimum Job Requirements

• Bachelor's Degree or 5 years of equivalent experience
• 3-5 years of related work experience in clinical research

Knowledge, Skills, and Abilities

• ACRP or CCRP Certificate preferred.
• Experience with submitting to various institutional research committees
• Ability to interact with the public, physicians, and staff.
• Ability to establish and maintain files and records.
• Willingness to work as a supportive, cooperative member of an interdisciplinary team.
• Demonstrated high-level communication skills to convey information concisely, synthesizing information and presenting it to others.
• Demonstrated problem solving capabilities to resolve concerns that arise unexpectedly.
• Demonstrated ability to research, properly evaluate information, and prepare concise, well-organized reports, summaries, and correspondence.
• Demonstrated ability to organize and prioritize a complex and dynamic workload.
• Ability to multitask and meet deadlines, despite interruptions.
• Ability to independently exercise discretion and sound judgment.
• Knowledge with various types of human subject clinical trials (i.e., National Group, Industrial, and Investigator-authored).
• Experience with clinical trial management and e-regulatory systems.
• Ability to work collegially and cooperatively in a small office and to establish and maintain cooperative working relationships.
• Ability to prioritize assignments and achieve high productivity/quality with short time frames, under rigid deadlines, and/or in environments with frequent workload changes and competing demands.
• Skill in working independently, taking initiative, and following through on assignments.
• Ability to think critically, compile data from various sources, analyze data, and prepare reports.
• Ability to work both independently and as part of team.
• Ability to take initiative and demonstrate strong commitment to duties.
• Ability to work within a deadline-driven structure.
• High level of integrity and honesty in maintaining confidentiality.
• Foster and promote a positive attitude and professional appearance.
• Strong attention to detail.
• Working knowledge of computer software including Microsoft Office (Outlook, Word, Excel, and PowerPoint).

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