Protocol Associate

3 weeks ago

Boston, United States ECOG-ACRIN MRF Full time
Job DescriptionJob Description

Position is currently hybrid with 1-2 days/week in the office. Seeking someone with oncology experience working with protocols

The Protocol Associate I assists with the coordination and development of ECOG-ACRIN sponsored clinical trials protocols from concept to activation on behalf of 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 DescriptionThe ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) is a multidisciplinary, membership-based scientific organization that designs and conducts biomarker-driven cancer research clinical trials involving adults who have or are at risk of developing cancer. ECOG-ACRIN consists of a headquarters location in Philadelphia, PA., and several fully staffed centers and offices, including an operations office and statistical data management center located in Boston, MA. The ECOG-ACRIN Cancer Research Group is a project of the ECOG-ACRIN Medical Research FoundationCompany DescriptionThe ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) is a multidisciplinary, membership-based scientific organization that designs and conducts biomarker-driven cancer research clinical trials involving adults who have or are at risk of developing cancer. ECOG-ACRIN consists of a headquarters location in Philadelphia, PA., and several fully staffed centers and offices, including an operations office and statistical data management center located in Boston, MA. The ECOG-ACRIN Cancer Research Group is a project of the ECOG-ACRIN Medical Research Foundation

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