Protocol Associate I

1 week ago

boston, United States ClinLab Staffing Full time

Job Title: Protocol Associate I


The Protocol Associate I assists with the coordination and development of sponsored clinical trials protocols from concept to activation on behalf of Medical Research Foundation. 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, and 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

Skills/Abilities

Exemplary interpersonal, communication and organizational skills.

This role necessitates motivation, organization, strict attention to detail, reliability and problem-solving skills.

Ability to manage multiple tasks and meet deadlines.

Ability to work as part of a team.

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

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