Title of Position: Protocol Associate I
Work Location: Boston, MA 02215
Temp to Perm
The Protocol Associate I assists with the coordination and development of Company sponsored clinical trials protocols from concept to activation.
The Protocol Associate I demonstrates utilization of time and resources in a cost efficient manner.
The Protocol Associate I is a professional and works as part of a team in conjunction with other clinical trial personnel as well as other healthcare providers and partners.
Policy and Procedure Interpretation
The Protocol Associate I operates within the guidelines established by the organization’s policies and procedures as well as other required regulations. The incumbent maintains the confidentiality of workplace information.
The Protocol Associate I will interact with other protocol development staff, project coordinators and managers, physicians, researchers, clinical research coordinators, consultants administrative and support staff and all affiliated professionals as appropriate, necessary and directed.
The Protocol Associate I works with highly confidential and proprietary information and must use discriminating judgement with this information. The incumbent may interact with physicians, consultants, vendors, contractors, clinical sites/personnel, pharmaceutical industry designees and governmental agencies as appropriate, necessary and directed.
The role of Protocol Associate I is primarily sedentary. Performance requires consistent attention to detail with extensive computer and customer service work. Reasonable accommodations will be made to comply with the Americans with Disabilities Act.
Work will be performed in an office setting. Basic operations will be located at a centrally designated corporate office. Travel if needed will be on a limited basis as needed to perform duties.
The Protocol Associate I role requires the following:
· 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 independently as well as part of a team.
· 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
· A Bachelor's degree in a life science discipline from an accredited college or university and/or life experience.
· Assists with all aspects involved in coordinating protocols for review, editing, and formatting the protocol/amendment for scientific and editorial accuracy and consistency.
· Coordinates the group wide notification of any change in study status, including activation, suspension, and termination.
· Maintains computer databases related to protocol development and status changes.
· Conducts quality control reviews of protocol documents for scientific and editorial accuracy and consistency.
· Interacts with other cooperative groups
· Contributes to development of protocol procedures.
· Performs database searches.
· Provides documentation of clinical trials protocols.
· Performs other duties as assigned.
The coming together of INC Research and inVentiv Health as one global company, called Syneos HealthTM, has created the industry’s only true end-to-end solution. This one entity combines world-renowned clinical research and commercialization capabilities with today’s most advanced science, business and data technologies to make real advances possible. We help you improve performance, reduce risk and expedite delivery of healthcare innovation to patients worldwide.
Role: Protocol Associate I
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