Boston, MA, USA
Dana-Farber Cancer Institute
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow’s physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
The Senior Regulatory Coordinator (RC) works under the direction of the Principal Investigator(s), Clinical Research Manager or directly for the Clinical Trials Office to complete the regulatory requirements of the clinical research project. The Senior 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), Quality Assurance of Clinical Trials (QACT), and the Clinical Trials Offices at the various DF/HCC institutions.
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 QACT, Industry Sponsors, and third party auditors.
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.
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
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
Bachelor’s degree (BA, BS) in life sciences, nursing, or other related discipline is required; Master’s or other advanced degree highly preferred.
3+ years of direct regulatory experience required.
Must have expert knowledge of FDA and ICH/GCP guidelines.
Previous experience with clinical trials and/or research coordination and personnel management required.
Has expert knowledge of and fully proficient in the following areas: 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.
Can demonstrate and articulate the above to staff and can act as a coach or mentor for regualtory staff.
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.
Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.
To apply, please visit the following URL:https://www.hospitalcareers.com/job/3685519/senior-regulatory-coordinator-pediatric-oncology-hematological-malignancy/→