Protocol Associate I.
Boston - United States
Depending on experience
Urgent hire ** Boston ** Hybrid working
Protocol Associate I
The Protocol Associate I assists with the coordination and development of clinical trials protocols from concept to activation. This is a non-exempt position.
- 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 protocols (Protrac and others) and status changes.
- 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 pharmaceutical companies.
- Prepares concept/LOI packets to be submitted to the 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.
- 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.
- Bachelor’s degree in a life science discipline from an accredited college or university and/or relevant professional experience is required.
- Health care 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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