Clinical Research Protocol Specialist

This is a fully remote position, open to applicants in Virginia.

📋 Description

• Collaborate with physician-scientists, researchers, and leadership in the development of clinical trial and research protocols, ranging from concept papers and letters of intent to the final protocol submission.

• Draft, revise, and manage protocol documents, informed consent forms, study procedures, and necessary regulatory documentation.

• Coordinate protocol development efforts across study teams, participating sites, and external partners.

• Assist investigators in navigating complex challenges related to protocol development, regulatory matters, operations, and submissions.

• Support the submission and amendment processes for Institutional Review Boards (IRBs), VA reviews, commercial IRBs, FDA submissions, and other regulatory bodies.

• Aid in the preparation and coordination of Investigational New Drug (IND) applications and related communications with the FDA.

• Assist in the formulation and execution of Cooperative Research and Development Agreements (CRADAs), collaborating with the Office of General Counsel and industry partners as necessary.

• Coordinate the initiation of studies and ensure compliance with protocol requirements, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and relevant regulatory standards.

• Monitor protocol development timelines, milestones, approvals, and deliverables across multiple simultaneous studies.

• Promote communication among investigators, clinical research teams, regulatory staff, sponsors, and participating study sites.

• Create protocol templates, guidance documents, and process enhancements to improve research operations and protocol development efficiency.

• Track progress and pinpoint risks that may affect 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 discipline.

• At least eight (8) years of experience in supporting clinical research, clinical trial operations, protocol development, regulatory affairs, or research program management.

• Proven experience in writing, developing, and coordinating clinical trial or research protocols.

• Experience in supporting protocol submissions to IRBs and other regulatory review bodies.

• Strong understanding of Good Clinical Practice (GCP), requirements for human subjects research, and clinical research regulations.

• Experience in coordinating activities across various stakeholders, research sites, and study teams.

• Excellent written communication skills with a proven track record in developing technical and scientific documentation.

• Outstanding organizational abilities and capacity to manage multiple concurrent projects and deadlines.

• Strong analytical, problem-solving, and interpersonal capabilities.

• Ability to work autonomously in a dynamic and fast-paced research environment.

• Capability to obtain and maintain a Public Trust clearance.

• Legal authorization to work in the United States.

🏝️ Benefits

• Health insurance

• Flexible working hours

• Professional development opportunities