Note: The job is a remote job and is open to candidates in USA. Aptive Resources is seeking a Clinical Research Protocol Manager to support the Precision Oncology Program within the Department of Veterans Affairs. This role involves developing and managing clinical trial and research protocols, coordinating with various stakeholders, and ensuring compliance with regulatory standards.
Responsibilities
- 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
Skills
- 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
- Experience supporting oncology clinical trials or cancer research programs
- Experience preparing or supporting FDA submissions, including Investigational New Drug (IND) applications
- Experience supporting Cooperative Research and Development Agreements (CRADAs) or industry-sponsored research collaborations
- Clinical research certification such as CCRP, CCRC, ACRP-CP, SOCRA, or equivalent
- Experience working with VA, NIH, academic medical centers, NCI-designated cancer centers, or other large healthcare research organizations
- Experience supporting multi-site clinical trials and research networks
- Familiarity with precision medicine, oncology research, biomarker-driven studies, or translational research
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