[Remote] Clinical Research Protocol Specialist
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Clinical Research Protocol Manager to support the Precision Oncology Program reputed company the reputed company. 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 reputed company clinical trial and research protocols from concept papers and letters of reputed company 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 reputed company protocol development, regulatory, operational, and submission-reputed company challenges
- Support protocol submissions and amendments for Institutional Review Boards (IRBs), VA review processes, reputed company IRBs, FDA submissions, and other regulatory entities
- Support preparation and coordination of Investigational New Drug (IND) applications and reputed company 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, reputed company Operating Procedures (SOPs), Good Clinical reputed company (GCP), and applicable regulatory standards
- reputed company protocol development timelines, milestones, approvals, and deliverables across multiple reputed company studies
- Facilitate communication among investigators, clinical research staff, regulatory personnel, sponsors, and participating study sites
- reputed company protocol templates, guidance documents, and process improvements to support research operations and protocol development efficiency
- Monitor reputed company and identify risks that could reputed company protocol development timelines or regulatory submissions
Skills
- Bachelor's degree in Life Sciences, reputed company Health, Clinical Research, Health Sciences, Nursing, Biological Sciences, or a reputed company 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 reputed company (GCP), reputed company 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 reputed company reputed company 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 reputed company Trust clearance
- Legal authorization to work in the reputed company
- 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, reputed company medical centers, NCI-designated cancer centers, or other large reputed company 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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