Research Protocol Specialist

Johns Hopkins University•Baltimore, MD

3d•$18 - $34•Hybrid

About The Position

We are seeking a Research Protocol Specialist who will provide administrative support for research centers, research review, and clinical trial committees. The Specialist will ensure that protocols and associated documents are processed, tracked, and maintained in compliance with institutional, regulatory, and sponsor requirements.

Requirements

High school diploma or graduation equivalent.
Three years of related experience.
Additional education may substitute for required experience and additional related experience may substitute for required education beyond high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.

Nice To Haves

Bachelor’s Degree.
Experience in a clinical research environment.

Responsibilities

Coordinate the submission, tracking, and scheduling of research protocols for internal review.
Review submissions for completeness and accuracy; manage protocol amendments and annual updates.
Maintain databases and tracking systems with up-to-date protocol status and outcome data.
Prepare and distribute review outcomes and communications to investigators and study staff.
Attend and document meetings related to protocol and safety reviews; track issues and resolutions.
Upload, organize, and maintain study-related documents in internal systems or libraries.
Enter study data into required institutional or sponsor registration systems.
Assist with protocol development, consent document drafting, and preparation of regulatory submissions.
Coordinate the research protocol documents and manage pre-written documents through development.
Coordinate research study logistics and support regulatory and operational approval processes.
Ensure compliance with institutional, sponsor, and federal requirements for research protocols.
Communicate with research sites, sponsors, and oversight bodies regarding study progress and requirements.
Coordinate projects, timelines, and priorities independently or as part of a team.
Participate in the development of standard operating procedures and internal workflows.
Support staff training as needed.
Other duties as assigned.