- Caris Life Sciences (Phoenix, AZ)
- …Caris is where your impact begins.** **Position Summary** A Clinical Trial Specialist -Biorepository provides operational and regulatory support for the ... science + 3-5 years' experience + Candidates should have experience with clinical trial regulatory documentation or TMF. + Candidates should have a… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The** **Position** The Clinical Trial Manager (CTM), Translational Medicine and Early Development (TMED) is responsible for assisting in ... vendors. The CTM will also assist to manage the clinical study team and help to coordinate meetings and...defining, monitoring and reporting on all aspects of key trial performance indicators, including for example, country and site… more
- Terumo Medical Corporation (Somerset, NJ)
- …for leading and executing clinical quality oversight activities across Terumo's clinical trials . This role ensures compliance with study protocols, of ISO ... Sr. Clinical Quality Specialist Date: Oct 21,.../ 14971, 21 CFR 50/56/812, and ICH-GCP and applicable regulatory requirements, while driving continuous improvement in clinical… more
- Parexel (Madison, WI)
- …of healthcare industry regulatory compliant data standards. + Good understanding of regulatory requirements & clinical trial design is preferred. **Why ... our team and support the design and execution of clinical trials through advanced analytics and evidence...+ Focus on exploratory work to generate evidence supporting clinical trial design, including outcome summaries and… more
- Caris Life Sciences (Tempe, AZ)
- …studies. The Global Companion Diagnostics Specialist will collaborate with Clinical Research, QA, Regulatory Affairs and other study stakeholders to ... collaboration with the appropriate cross-functional teams. The Global Companion Diagnostics Specialist will support clinical study compliance through creation… more
- WCG Clinical (Cary, NC)
- …solutions that stimulate growth, foster compliance, and maximize efficiency for those performing clinical trials . WCG is proud to serve individuals on the ... WCG IRB Operations Specialist (Remote) **General Information** **Organization:** WCG IRB **Job...Time - Regular **Description and Requirements** **ABOUT WCG:** WCG's clinical solutions are built on a foundation of best-in-class… more
- Principal Financial Group (Denver, CO)
- …detailed proprietary analysis of therapeutics companies globally leveraging: + comprehensive clinical pipeline, trial data, commercial forecasting / competitive ... + relevant medical and scientific publications / meeting updates + FDA regulatory developments and policy actions / announcements + Interact frequently with company… more
- Parexel (Bismarck, ND)
- …studies, as applicable and/or appropriate for the MD + Providing risk assessment of clinical trials for local sponsorship as needed with the support of the ... papers, slide sets, publications etc. Skills - Experience in clinical medicine (general or specialist qualifications) with...-Experienced as a Physician in Industry or as a clinical trial investigator with significant clinical… more
- Middlesex Health (Hartford, CT)
- …* Support research initiatives by providing tumor registry data for studies and clinical trials . * Assist in tracking patient outcomes and treatment patterns ... week * Shift: Shift 1 Position Summary The Tumor Registrar (Oncology Data Specialist ) assures thorough, accurate and quality data collection as required by the… more
- University of Pennsylvania (Philadelphia, PA)
- …of health and wellness programs and resources, and much more. Posted Job Title Clinical Research Regulatory Specialist B (Abramson Cancer Center) Job Profile ... Title Clinical Research Regulatory Specialist B Job Description Summary The...-CC to participate in the coordination of Phase I-V clinical trials . Reporting to the Regulatory… more
- Baylor Scott & White Health (Dallas, TX)
- **JOB SUMMARY** The Clinical Research Regulatory Specialist supports clinical research activities through the development of protocol-specific documents ... to research involving human subjects. This position also provides regulatory guidance and direction to internal clinical ... requirements are met, to include ensuring requirements for trial registration, results and reporting are completed in a… more
- University of Pennsylvania (Philadelphia, PA)
- …of unit research, including but not limited to Phase I-IV clinical trials . The Regulatory Affairs Specialist C will, independently prepare and ... documentation/ Trial Master files (TMF) as required. The Regulatory Affairs Specialist C is expected to...but not limited to Phase I-IV clinical trials . The Regulatory Affairs Specialist … more
- Houston Methodist (Houston, TX)
- …event reports, safety reports, and notifies IRB of study closures. + Maintains the required regulatory files for all clinical trials to ensure regulatory ... and study specific protocols/plans and processes. The Regulatory Compliance Specialist position maintains documentation for clinical research studies, case… more
- Hackensack Meridian Health (Hackensack, NJ)
- …Minimum of 2 years experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or at least 4 years related experience in the field ... and overseeing clinical operations of all assigned clinical trials and participates in assessing, planning,...general supervision of the principal investigator responsible for the clinical trial (s) to which is assigned. **Education,… more
- HonorHealth (AZ)
- …(CTMS), and familiarity with basic finance and accounting principles. The successful Clinical Trial Operations Specialist will support Research Program ... Research Administration, and the research staff. The tasks the Clinical Trial Operations Specialist must...closely with Principal Investigators, Clinical Program Leads, Regulatory , Finance, Clinical Trials Personnel,… more
- Terumo Neuro (Aliso Viejo, CA)
- **12870BR** **Title:** Sr Specialist , Clinical Trial Quality Assurance **Job Description:** Provide support to all aspects of the Clinical Quality ... Hiring Ordinance, and San Francisco Fair Chance Ordinance. **External-Facing Title:** Sr Specialist , Clinical Trial Quality Assurance **Posting Country:** US… more
- Houston Methodist (Houston, TX)
- …accurate data collection, documentation organization, and safety of study volunteers. Ensures accurate regulatory filing. + Assists Clinical Trial Manager in ... is responsible for supporting multiple projects under supervision of Clinical Trial Manager which may include ...from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research… more
- Sumitomo Pharma (St. Paul, MN)
- …International Council for Harmonization E6(R2). + Fundamental knowledge of the conduct of clinical trials is preferred. + Strong focus on teamwork, attention to ... our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. The Trial Master File (TMF) Specialist will be...ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure… more
- Georgetown Univerisity (Washington, DC)
- …Diseases Clinical Trials Unit will work with and assist the Clinical Research Coordinator, Regulatory Specialist , and Clinical Trial ... the Clinical Research Coordinator, Regulatory Specialist , and Clinical Trial Manager...7 years of experience working with clinical trials and supporting a clinical trial… more
- University of Utah (Salt Lake City, UT)
- …Quality Oversight** + Conduct routine internal audits and targeted reviews of clinical trial documentation including regulatory binders, subject binders ... research study teams, and clinical teams, the QA Specialist ensures regulatory compliance, operational efficiency, and consistently high standards… more
