Regulatory Specialist

Job Description

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.

Essential 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.
• Oversee reporting of AEs, SAEs, IND safety data, violations, deviations and submission of other study documents to support regulatory compliance, and troubleshoot processes and procedures when issues are identified.
• Affiliate with 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.
• Affiliate in the preparation and implementation of regulatory office SOPs.

Required Qualifications

• Bachelor's degree required in Life Science or related field.
• Master's degree preferred in Regulatory Affairs.
• One - three years of previous clinical trial regulatory affairs experience.
• 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.

Preferred Qualifications

• Five years equivalent experience in a clinical research and regulatory environment.

Pay Range

$60,080.00 USD - $88,005.00 USD