Solutions That Connect
Clinical Research Protocol Specialist
Location
Virginia
Posted
3 days ago
Salary
0
Seniority
Lead
Job Description
Clinical Research Protocol Specialist
Aptive Resources
• 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.
Job 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.
Benefits
- Health insurance
- Flexible working hours
- Professional development opportunities
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