Protocol Associate

About the Role

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.

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.