Protocol Associate - Oncology Clinical Research (Hybrid)

Job Description

Job Description

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.

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.

The ECOG-ACRIN Medical Research Foundation (EAMRF) serves as the grantee organization for the ECOG-ACRIN Cancer Research Group (Group). As a unique nonprofit organization, the overarching mission is to improve and increase patient awareness as well as facilitate access and promote participation in adult oncology clinical trials. The EAMRF provides the necessary support for EA to coordinate the scientific, administrative, governance and membership activities of the Group.

The EAMRF provides the support required to conduct oncology clinical trials. All the trials conducted under the auspices of the Group benefit public health by improving the quality and standard of care of patients with cancer. In addition, the organization promotes collaboration across the scientific community and encourages engagement of patient advocacy at all levels.

Company Description

The ECOG-ACRIN Medical Research Foundation (EAMRF) serves as the grantee organization for the ECOG-ACRIN Cancer Research Group (Group). As a unique nonprofit organization, the overarching mission is to improve and increase patient awareness as well as facilitate access and promote participation in adult oncology clinical trials. The EAMRF provides the necessary support for EA to coordinate the scientific, administrative, governance and membership activities of the Group.\r\n\r\nThe EAMRF provides the support required to conduct oncology clinical trials. All the trials conducted under the auspices of the Group benefit public health by improving the quality and standard of care of patients with cancer. In addition, the organization promotes collaboration across the scientific community and encourages engagement of patient advocacy at all levels.