We are seeking an experienced Protocol Associate with a strong background in oncology clinical research and clinical trial protocol development. This role supports the coordination, development, and activation of ECOG-ACRIN-sponsored clinical trial protocols on behalf of the ECOG-ACRIN Medical Research Foundation (EAMRF). This position offers the opportunity to work with nationally recognized investigators and contribute to cutting-edge cancer research.
Hybrid Schedule: This position requires working 1–2 days per week in our Boston office, with the remainder of the week working remotely.
Competitive salary of $50,000–$70,000, based on experience
Key Responsibilities
- Coordinate all phases of assigned clinical trial protocols, from concept development through study activation.
- Manage protocol development activities, including concept review, protocol preparation, NCI and CIRB submissions, responses, quality control, timeline tracking, and protocol amendments.
- Review, edit, and format protocols and amendments to ensure scientific accuracy, consistency, and compliance.
- Serve as a primary point of contact for disease committee chairs, investigators, and other research collaborators.
- Coordinate and communicate study status changes, including activations, suspensions, amendments, and study closures.
- Maintain protocol development databases, ClinicalTrials.gov records, and internal tracking systems.
- Plan and facilitate monthly disease committee teleconferences, prepare meeting agendas, generate tracking reports, and document action items.
- Prepare concept and Letter of Intent (LOI) submission packets for Executive Committee review.
- Review concepts and LOIs before submission to the Executive Committee, Steering Committee, and the National Cancer Institute (NCI).
- Coordinate protocol review meetings, study concept discussions, and disease-specific working group conference calls.
- Collaborate with investigators, cooperative research groups, the NCI, member institutions, and study coordinators throughout the protocol development process.
- Contribute to the development and maintenance of protocol procedures and departmental documentation.
- Perform database searches, maintain project records, and support additional departmental initiatives as assigned.
Qualifications
- Bachelor's degree in a life sciences discipline or an equivalent combination of education and relevant professional experience.
- Experience working in an oncology clinical research environment.
- Experience supporting clinical trial protocol development and management is strongly preferred.
- Healthcare or clinical research background.
- Clinical operations and/or clinical data management experience.
- Strong organizational skills with the ability to manage multiple projects and deadlines.
- Excellent written, verbal, and interpersonal communication skills.
- Proficiency with Microsoft Office and database applications.
- Experience with electronic data submission systems is a plus.
- Commitment to accuracy, collaboration, and delivering high-quality work in a fast-paced research environment.
Pay: $50,000.00 - $70,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
Education:
Experience:
- oncology clinical research: 2 years (Required)
Ability to Commute:
- Boston, MA 02109 (Required)
Work Location: Hybrid remote in Boston, MA 02109
