Oncology Clinical Trials Regulatory Specialist

Anna Jaques Hospital; Boston (MA); On-site; USD 60,000 - 88,000; Full time

Job summary

The Cancer Clinical Trials Office at Beth Israel Deaconess Medical Center (BIDMC) seeks a regulatory affairs professional to support 12 cancer disease programs. You will prepare consent forms, submit to IRB, and manage regulatory documentation for industry and PI initiated studies.

Responsibilities include IND filings, annual FDA reports, and liaison work with IRB; a bachelor’s in Life Science is required, with 1–3 years of experience and strong knowledge of FDA guidelines.

Qualifications

• Bachelor's degree in Life Science or related field is required; Master's in Regulatory Affairs preferred.
• 1-3 years related work experience in regulatory affairs.
• Knowledge of FDA, cooperative groups, NCI and OHRP regulatory guidelines.
• Maintain confidentiality and work independently and with teams.
• Experience with computer systems and MS Office applications (Outlook, Word, Excel, PowerPoint, Access).

Responsibilities

• Prepare and submit applications and consent forms to IRB and assist with study activation.
• Prepare protocol amendments, ADEER reports, IND safety data and regulatory submissions.
• Assist in IND applications to FDA and annual reports to FDA; submit documents to NIH and other bodies.
• Serve as liaison between IRB and investigators to resolve regulatory queries.
• Assist in developing and implementing regulatory office SOPs.

Skills

Written Communications

Oral Communications

Knowledge

Team Work

Customer Service

Education

Bachelor's degree in Life Science

Master's degree in Regulatory Affairs

Tools

Microsoft Office

Job description

The Cancer Clinical Trials Office at Beth Israel Deaconess Medical Center (BIDMC) seeks a regulatory affairs professional to support 12 cancer disease programs. You will prepare consent forms, submit to IRB, and manage regulatory documentation for industry and PI initiated studies.

Responsibilities include IND filings, annual FDA reports, and liaison work with IRB; a bachelor’s in Life Science is required, with 1–3 years of experience and strong knowledge of FDA guidelines.