Protocol Associate

Job Description

Job Description

The position is currently hybrid, requiring 1–2 days per week in the office.

We are seeking a candidate with oncology experience, particularly working with clinical trial protocols.

The Protocol Associate supports the coordination and development of ECOG-ACRIN–sponsored clinical trial protocols, from initial concept through activation, on behalf of the ECOG-ACRIN Medical Research Foundation (EAMRF). This is a non-exempt position.

Responsibilities:

• Oversees assigned disease committees in all aspects of protocol development, which includes, but is not limited to, concept development, protocol development, NCI and CIRB submissions and responses, quality control reviews, tracking development (e.g., OEWG) timelines, and initiating addenda when needed
• Assists with all aspects involved in coordinating protocols for review, editing, and formatting the protocol/amendment for scientific and editorial accuracy and consistency with oversight from Project Coordinator
• Coordinates the group-wide notification of any change in study status, including activation, suspension, and termination
• Assists as lead contact for disease chairs, investigators and other senior level colleagues
• Maintains computer databases related to protocol development and status changes
• Plans and manages monthly teleconferences for assigned disease sites
• Generates committee tracking documents for use on monthly teleconferences
• Prepares high-level notes containing action items from monthly teleconferences
• Maintains computer databases related to protocol statuses (clinicaltrials.gov records and internal tracking)
• Participates in departmental meetings, protocol development meetings, disease-specific committee meetings, and other conference calls as required
• Interacts with other cooperative groups, the NCI, member coordinators and investigators
• Prepares concept/LOI packets to be submitted to the ECOG-ACRIN Executive Committee in a timely manner on a monthly basis
• Reviews concepts/LOIs prior to Executive Committee, Steering Committee, and NCI submission
• Sets up various conference calls on an as needed basis such as: study concept/LOI calls, disease specific working group calls, and protocol review calls
• Contributes to development of protocol procedures
• Performs database searches
• Performs other duties as assigned by Protocol Development management

Job Requirements - Education/Experience

• Bachelor’s degree in a life science discipline from an accredited college or university and/or relevant professional experience is required
• Healthcare related background
• Prior clinical and/or data services experience
• Proficiency in database and word processing skills, and MS Office
• Strong customer service skills
• Knowledge/experience with electronic data submission a plus

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.

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.