[Remote] Clinical Research Protocol Specialist

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, coordinating, and managing clinical trial and research protocols while providing specialized protocol development and regulatory coordination support to physician-scientists conducting high-impact oncology research.ResponsibilitiesCollaborate with physician-scientists, investigators, and research leadership to develop clinical trial and research protocols from concept papers and letters of intent through final protocol submissionDraft, edit, and manage protocol documents, informed consent forms, study procedures, and supporting regulatory documentationCoordinate protocol development activities across study teams, participating sites, and external partnersAssist investigators in resolving complex protocol development, regulatory, operational, and submission-related challengesSupport protocol submissions and amendments for Institutional Review Boards (IRBs), VA review processes, commercial IRBs, FDA submissions, and other regulatory entitiesSupport preparation and coordination of Investigational New Drug (IND) applications and related FDA communicationsAssist with development and execution of Cooperative Research and Development Agreements (CRADAs) and coordination with the Office of General Counsel and industry partners as neededCoordinate study startup activities and support compliance with protocol requirements, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory standardsTrack protocol development timelines, milestones, approvals, and deliverables across multiple concurrent studiesFacilitate communication among investigators, clinical research staff, regulatory personnel, sponsors, and participating study sitesDevelop protocol templates, guidance documents, and process improvements to support research operations and protocol development efficiencyMonitor progress and identify risks that could impact protocol development timelines or regulatory submissionsSkillsBachelor's degree in Life Sciences, Public Health, Clinical Research, Health Sciences, Nursing, Biological Sciences, or a related fieldMinimum of eight (8) years of experience supporting clinical research, clinical trial operations, protocol development, regulatory affairs, or research program managementDemonstrated experience writing, developing, and coordinating clinical trial or research protocolsExperience supporting protocol submissions to IRBs and other regulatory review bodiesWorking knowledge of Good Clinical Practice (GCP), human subjects research requirements, and clinical research regulationsExperience coordinating activities across multiple stakeholders, research sites, and study teamsStrong written communication skills with demonstrated experience developing technical and scientific documentationExceptional organizational skills and ability to manage multiple concurrent projects and deadlinesStrong analytical, problem-solving, and interpersonal skillsAbility to work independently in a fast-paced and evolving research environmentAbility to obtain and maintain a Public Trust clearanceLegal authorization to work in the United StatesExperience supporting oncology clinical trials or cancer research programsExperience preparing or supporting FDA submissions, including Investigational New Drug (IND) applicationsExperience supporting Cooperative Research and Development Agreements (CRADAs) or industry-sponsored research collaborationsClinical research certification such as CCRP, CCRC, ACRP-CP, SOCRA, or equivalentExperience working with VA, NIH, academic medical centers, NCI-designated cancer centers, or other large healthcare research organizationsExperience supporting multi-site clinical trials and research networksFamiliarity with precision medicine, oncology research, biomarker-driven studies, or translational researchCompany OverviewAptive Resources is a management consulting firm focused on human experience, digital services and business transformation. It was founded in 2008, and is headquartered in Alexandria, Virginia, USA, with a workforce of 501-1000 employees. Its website is https://www.aptiveresources.com/.