Clinical Research Protocol Specialist

Role Overview

• Collaborate with physician-scientists, investigators, and research leadership to develop clinical trial and research protocols from concept papers and letters of intent through final protocol submission.
• Draft, edit, and manage protocol documents, informed consent forms, study procedures, and supporting regulatory documentation.
• Coordinate protocol development activities across study teams, participating sites, and external partners.
• Assist investigators in resolving complex protocol development, regulatory, operational, and submission-related challenges.
• Support protocol submissions and amendments for Institutional Review Boards (IRBs), VA review processes, commercial IRBs, FDA submissions, and other regulatory entities.
• Support preparation and coordination of Investigational New Drug (IND) applications and related FDA communications.
• Assist with development and execution of Cooperative Research and Development Agreements (CRADAs) and coordination with the Office of General Counsel and industry partners as needed.
• Coordinate study startup activities and support compliance with protocol requirements, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory standards.
• Track protocol development timelines, milestones, approvals, and deliverables across multiple concurrent studies.
• Facilitate communication among investigators, clinical research staff, regulatory personnel, sponsors, and participating study sites.
• Develop protocol templates, guidance documents, and process improvements to support research operations and protocol development efficiency.
• Monitor progress and identify risks that could impact protocol development timelines or regulatory submissions.

Requirements

• Bachelor's degree in Life Sciences, Public Health, Clinical Research, Health Sciences, Nursing, Biological Sciences, or a related field.
• Minimum of eight (8) years of experience supporting clinical research, clinical trial operations, protocol development, regulatory affairs, or research program management.
• Demonstrated experience writing, developing, and coordinating clinical trial or research protocols.
• Experience supporting protocol submissions to IRBs and other regulatory review bodies.
• Working knowledge of Good Clinical Practice (GCP), human subjects research requirements, and clinical research regulations.
• Experience coordinating activities across multiple stakeholders, research sites, and study teams.
• Strong written communication skills with demonstrated experience developing technical and scientific documentation.
• Exceptional organizational skills and ability to manage multiple concurrent projects and deadlines.
• Strong analytical, problem-solving, and interpersonal skills.
• Ability to work independently in a fast-paced and evolving research environment.
• Ability to obtain and maintain a Public Trust clearance.
• Legal authorization to work in the United States.

Tech Stack

• Google Cloud Platform

Benefits

• Health insurance
• Flexible working hours
• Professional development opportunities