Clinical Research Protocol Specialist

Aptive•UNAVAILABLE, UNAVAILABLE

2h•Remote

About The Position

Aptive Resources is seeking a Clinical Research Protocol Manager to support the Precision Oncology Program within the Department of Veterans Affairs (VA) Office of Research and Development (ORD) under the Field Enterprise Research Support Services (FERSS) contract. The Precision Oncology Program supports the development and implementation of innovative cancer research initiatives designed to improve outcomes and access to care for Veterans. As part of a broader effort to harmonize oncology research activities across the VA enterprise and support the development of a national cancer clinical research network, this position will provide specialized protocol development, regulatory coordination, and clinical research support to physician-scientists conducting high-impact oncology research. The Clinical Research Protocol Manager will work directly with investigators, physician-scientists, and research leadership to develop, coordinate, and manage clinical trial and research protocols from concept development through final protocol submission and implementation. This position requires an experienced clinical research professional with demonstrated protocol development expertise, strong knowledge of clinical research regulations and submission processes, and the ability to operate independently in a fast-paced environment while providing immediate value with minimal onboarding. This is a full-time (40 hours/week), 100% remote position. This position is currently funded through September 29, 2026 under the current contract period of performance, with potential for extension into the next option year based on contract continuation and program needs.

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.

Nice To Haves

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.

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.