Protocol Associate

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 neededAssists 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 CoordinatorCoordinates the group-wide notification of any change in study status, including activation, suspension, and terminationAssists as lead contact for disease chairs, investigators and other senior level colleaguesMaintains computer databases related to protocol development and status changesPlans and manages monthly teleconferences for assigned disease sitesGenerates committee tracking documents for use on monthly teleconferencesPrepares high-level notes containing action items from monthly teleconferencesMaintains 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 requiredInteracts with other cooperative groups, the NCI, member coordinators and investigatorsPrepares concept/LOI packets to be submitted to the ECOG-ACRIN Executive Committee in a timely manner on a monthly basisReviews concepts/LOIs prior to Executive Committee, Steering Committee, and NCI submissionSets up various conference calls on an as needed basis such as: study concept/LOI calls, disease specific working group calls, and protocol review callsContributes to development of protocol proceduresPerforms database searchesPerforms other duties as assigned by Protocol Development managementJob Requirements - Education/ExperienceBachelor's degree in a life science discipline from an accredited college or university and/or relevant professional experience is requiredHealthcare related backgroundPrior clinical and/or data services experienceProficiency in database and word processing skills, and MS OfficeStrong customer service skillsKnowledge/experience with electronic data submission a plusCompany DescriptionThe 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 DescriptionThe 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.