Regulatory Coordinator - Thoracic Oncology Job at Dana-Farber Cancer Institute (Brookline)

Job Description

The Regulatory Coordinators (RC) works under the direction of the Thoracic Oncology Principal Investigator(s), Regulatory Operations Manager, Clinical Research Manager and / or directly for the Clinical Trials Office to complete the regulatory requirements of the clinical research project. The RC coordinates aspects of protocol submissions, prepares and submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal regulation and ICH/GCP guidelines. This position will work collaboratively with a variety of personnel at all levels, including faculty and study team members of DF/HCC and external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations. Works interactively with the Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the various DF/HCC institutions.

Job Responsibility

Regulatory Compliance: Prepares and submits all protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval
Prepares and submits regulatory documentation that may include
IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies including the Food and Drug Administration (FDA), Office of Biotechnology Activities (OBA), etc
Prepares, maintains and organizes Regulatory files for each assigned study in compliance with study sponsor requirement
Industry sponsor, DF/HCC sponsored etc
Maintains various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion
Assists in the preparation and coordination of assigned study monitoring and auditing visits with study coordinator, Investigator, DF/HCC ODQ, Industry Sponsors, and third-party auditors
Leadership and Professionalism: Maintain working knowledge of current regulations, regulatory guidance and or local policies
Assists Clinical research Manager with regulatory based training and implementation of new or revised regulation, guidance and or local policy
Present regulatory status for disease group portfolio at applicable research meetings
Key Stakeholder Interfacing: Establishing and maintaining regular communication with study team, study sponsor, applicable regulatory agencies / offices to ensure all required information is relayed and responsible for the systematic documentation / tracking when applicable
Serve as facilitator for study team and sponsor with regard to study status information, critical safety issues, upcoming protocol, consent and IDB amendments and applicable protocol training
responsible for the systematic documentation / tracking when applicable
Clinical Trial Management: Track and manage assigned new protocol start-up packet
initiate, facilitate, and monitor study start-up progress to ensure established benchmarks are met
Communicate and collaborate with clinical trial key stakeholders through the start-up process, provide regular updates and ensure all start-up activities are completed
Create and maintain tracking for all subsequent submissions to the SRC / IRB
protocol & consent amendments, all required safety reporting, all required deviation, violation, exception, or other event reporting
Ensure various regulatory reporting required are met
Study Sponsor, FDA, IRB etc
Responsible for data entry of Subject Visit Tracking information (as applicable for role) into Clinical Trial Management System contemporaneously with medical visits, assessments, and other subject-specific information
Responsible for data entry of time and effort spent on study-specific activities and other administrative tasks into Clinical Trial Management System contemporaneously with work completed
Responsible for data entry of study-specific activity, including but not limited to monitor visits, external site enrollment, amendments, receipt of Safety Reports, etc. into Clinical Trial Management System contemporaneously with activity completed.

Requirements

Bachelor’s Degree or 1 year of Dana-Farber Associate Regulatory Coordinator experience required
0-1 years of experience working in a medical or scientific research setting or comparable technology orientated business environment preferred
Fundamental knowledge of the conduct of clinical trials is preferred
Must possess excellent written and oral communication skills, maintain confidentiality of information, demonstrate good decision-making and judgment and have attention to detail and follow-through skills
Demonstrated organization and time management/prioritization skills with the ability to work independently are required
Must be proficient in the use of computers, Microsoft applications and databases
Requires experience with medical terminology
Must be able to perform day to day responsibilities duties as described above with regular and ongoing training and supervision
Attains and can demonstrate fundamental knowledge and is somewhat proficient in some or all of the following areas: DFCI, DF/HCC, ICH/GCP, FDA policy / guidance / regulation
an understanding of the IRB submission & approval process
Regulatory Binder maintenance
PI Initiated / Multi-Center Trials
protocol and consent design and development and FDA IND and other regulatory required submissions.

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Regulatory Coordinator - Thoracic Oncology

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