Lead Research Associate - Protocol Specialist - Hybrid

Westat•Bethesda, MD

5d•Hybrid

About The Position

Westat is seeking a Lead Research Associate - Protocol Specialist to support a dynamic portfolio of clinical research projects. In this role, you will coordinate the end-to-end protocol development process with clients and multidisciplinary stakeholders, manage meetings and document workflows, and ensure strong version control across key study materials. As protocols move toward activation, you will also support training and site management activities throughout the study lifecycle. This is a hybrid role, requiring 3 days per week on-site in Westat's Bethesda, Maryland office.

Requirements

MA/MS/MPH in epidemiology, public health, or related scientific research degree with 2-4 years of relevant experience; or a bachelor's degree in epidemiology, public health, or related scientific research degree with 8 or more years of relevant experience.
Excellent verbal and written communication skills for client-facing meetings and site management and support
Strong interpersonal skills and ability to work effectively and collaboratively within a team environment
Proven ability to work independently

Nice To Haves

Experience with clinical research, specifically protocol development and implementation
Experience with Institutional Review Boards and coordinating regulatory submission across multiple sites
Knowledge of MS office products, Box, and RedCap Cloud

Responsibilities

Apply knowledge of clinical intervention protocols and underlying clinical trials and epidemiological methods
Translate scientific discussions, materials, and metrics into clear notes, reports, and presentations
Work with internal and external teams to support the development and implementation of clinical protocols
Coordinate and contribute to the development of study concepts, protocols, informed consent forms, and MOPs
Develop and maintain study timelines for study concept development, protocol documents, participant-facing materials, implementation tools, and case report forms
Coordinate and manage regulatory submissions in conjunction with the Regulatory Affairs Manager
Assist with development of protocol-specific management plans, as needed.
Ensure proper storage and maintenance of required essential documents