Regulatory Specialist
About The Position
This position is in the Cancer Clinical Trials Office (CCTO), supporting multiple disease centers. The CCTO provides patients with experimental treatment options that go beyond the standard of care. The Cancer Research Institute's researchers are responsible for breakthroughs across the spectrum of cancer science, from genetics to signal transduction to RNA medicine and beyond. BIDMC, a founding member of the Dana-Farber/Harvard Cancer Center, is a major recipient of funding from the National Institutes of Health. Job Summary: The Cancer Clinical Trials Office (CCTO) at Beth Israel Deaconess Medical Center (BIDMC) supports clinical research and provides infrastructure and services to 12 individual cancer disease programs: AIDS Oncology, Breast Oncology, Cutaneous Oncology, Experimental Therapeutics, Gastrointestinal Oncology, Genitourinary Oncology, Gynecological Oncology, Hematological Malignancies/Bone Marrow Transplant, Radiation Oncology, Renal Oncology, Thoracic Oncology, and Thrombosis/Benign Hematology.
Requirements
- Bachelor's degree required in Life Science or related field.
- 1-3 years related work experience required.
- One - three years of previous clinical trial regulatory affairs experience.
- Must demonstrate good understanding of FDA, cooperative group, NCI and OHRP regulatory guidelines.
- Must maintain confidential and sensitive information, set own priorities, and work both independently and collaboratively with other research and hospital personnel.
- Experience with computer systems required, including web based applications and some Microsoft Office applications which may include Outlook, Word, Excel, PowerPoint or Access.
Nice To Haves
- Master's degree preferred in Regulatory Affairs
- Five years equivalent experience in a clinical research and regulatory environment.
Responsibilities
- Prepare and submit applications, including preparation of consent forms to the DFHCC IRB on all cancer center clinical trials (industry, cooperative groups and PI initiated studies), and respond to IRB comments on applications submitted and work with study team in getting studies activated for enrollment of patients.
- Prepare and assist in submission of protocol amendments, IND safety reports, ADEERS submission, consent form changes, continuing reviews, violations and deviations to study protocols. Oversees reporting of AEs, SAEs, IND safety data, violations, deviations and submission of other study documents to support regulatory compliance, and troubleshoots processes and procedures when issues are identified.
- Assist investigators and study teams in preparing and submitting IND applications to the FDA. Preparation and submission of annual reports to the FDA. Submission of regulatory documents to NIH/OBA, local bio safety committees on oncology human gene transfer trials.
- Act as a liaison between the DFHCC IRB and investigator to resolve regulatory queries and concerns.
- Assist in the preparation and implementation of regulatory office SOPs.
Benefits
- Vaccinated against influenza (flu) as a condition of employment.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
