Oncology Clinical Trials Regulatory Specialist

Beth Israel Lahey Health; Boston (MA); On-site; USD 60,000 - 88,000; Full time

Job summary

Beth Israel Lahey Health's Cancer Clinical Trials Office (CCTO) at BIDMC supports clinical research across 12 cancer disease programs, providing infrastructure and services for trial activation and regulatory compliance. The role involves preparing IRB submissions, amendments, and regulatory documents to ensure trials meet all guidelines.

Ideal candidates have a life science degree with regulatory affairs training and 1–3 years of clinical trial regulatory experience, plus strong written and

Qualifications

• Bachelor’s degree in Life Science or related field.
• Master’s degree in Regulatory Affairs preferred.
• 1-3 years related work experience required.
• Must demonstrate good understanding of FDA, cooperative group, NCI and OHRP regulatory guidelines.
• Experience with computer systems required, including web based applications and Microsoft Office applications.

Responsibilities

• Prepare and submit IRB applications for cancer center trials; respond to IRB comments and activate studies.
• Prepare protocol amendments, IND safety reports, ADEERS submissions, and regulatory documents; oversee AE/SAE reporting.

Skills

Regulatory affairs

Written English

Oral communication

Teamwork

Customer service

Education

Bachelor’s degree in Life Science or related field

Master’s degree in Regulatory Affairs

Tools

Microsoft Office

Job description

Beth Israel Lahey Health's Cancer Clinical Trials Office (CCTO) at BIDMC supports clinical research across 12 cancer disease programs, providing infrastructure and services for trial activation and regulatory compliance. The role involves preparing IRB submissions, amendments, and regulatory documents to ensure trials meet all guidelines.

Ideal candidates have a life science degree with regulatory affairs training and 1–3 years of clinical trial regulatory experience, plus strong written and