- Novo Nordisk Inc. (Plainsboro, NJ)
- …and strategic partnership negotiations in accordance with all relevant regulations and policies; ( Good Clinical Practice ( GCP ), ICH guidelines, federal ... schedules) Advanced knowledge of regulatory and compliance requirements for clinical research, ICH GCP Principles and the...Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …competency in coaching and training of clinical research staff Advanced knowledge of Good Clinical Practice ( GCP ), ICH Guidelines, federal and local ... and clinical research process Strong solution-oriented customer focus Good communication, collaboration and influencing skills We commit to an inclusive… more
- Merck & Co. (Rahway, NJ)
- …(FDA), Office of Inspector General (OIG), Health Insurance Portability and Accountability Act (HIPAA), Good Clinical Practice ( GCP ) and other ethical ... as needed across CVM programs.Collaborates with other EDs to ensure best- practice sharing among different USMA FM teams.Strategic Planning and Project… more
- Merck & Co. (Rahway, NJ)
- …collaboration with other functions within and outside of GCTO to ensure that Good Clinical Practice Health Authority inspections are adequately supported ... and Mentoring:-Collaborate with cross-functional teams to support and adequately manage Good Clinical Practice Health Authority inspections. Additionally,… more
- Eisai, Inc (NJ)
- …degree.Minimum 7-10 years procurement experience, minimum 7 years pharmaceutical/ clinical outsourcing.In-depth understanding of GCP /GLP guidelines, audit ... to hear from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and support activities...as necessary.Highly proficient in MS Office Suite with a good understanding of other IT systems for contract management… more
- George Washington University (Washington, DC)
- …Minimum Qualifications: Preferred Qualifications: Strong understanding of Human Subjects Protections, Good Clinical Practice ( GCP ), International ... key focus of the GWU SMHS is to perform clinical translational research for neglected tropical diseases. Our goal...Assistant will assist the Principal Investigator (PI) with the clinical trials at GW and in Barranquilla, Colombia. This… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …of Standard Operating Procedures (SOPs), FDA regulations, and International Conference on Harmonization/ Good Clinical Practice (ICH/ GCP ) guidelines. ... the Role:Job SummaryResponsible for the coordinating, implementing, and evaluating of clinical research trials. This includes all phases of research: Study… more
- Cynet Systems Inc. (Irvine, CA)
- …with FDA guidelines for Software Quality and Systems Validation is a plus. Knowledge of Good Clinical practice ( GCP ), Good pharmacovigilance ... Practice (GVP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP).Experience in… more
- GE HealthCare (Boston, MA)
- **Job Description Summary** The Good Clinical Practice ( GCP ) Senior Quality Assurance (QA) Auditor is crucial in ensuring that clinical trials are ... + Training and Education: They may provide training to clinical trial personnel on GCP requirements, SOPs, and best practices to ensure understanding and… more
- Philips (Orange, OH)
- The Senior Good Clinical Practice ( GCP ) Auditor will play a critical role in ensuring Philips' Clinical Studies and practices are compliant with ... Internal/External regulatory and quality standards. **Your role:** + Executing & leading Good Clinical Practice ( GCP ) audits in line with defined… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …in a Clinical Development role. Strong Expertise with transferable skills related to Good Clinical Practice ( GCP ), and/or Good Pharmacovigilance ... The Senior Manager, Global Development Quality Management ( GCP ) acting as a Quality Management Lead (QML) is a key position that will provide mentorship and… more
- University of Pennsylvania (Philadelphia, PA)
- …any necessary testing and appointment coverage according to protocol and in accordance with Good Clinical Practice (" GCP ") (eg scheduling subject visits ... testing and appointment coverage according to protocol and in accordance with Good Clinical Practice (" GCP ") (eg scheduling subject visits within… more
- University of Pennsylvania (Philadelphia, PA)
- …any necessary testing and appointment coverage according to protocol and in accordance with Good Clinical Practice (" GCP ") (eg scheduling subject visits ... testing and appointment coverage according to protocol and in accordance with Good Clinical Practice (" GCP ") (eg scheduling subject visits within… more
- University of Pennsylvania (Philadelphia, PA)
- …any necessary testing and appointment coverage according to protocol and in accordance with Good Clinical Practice ( GCP ) (eg scheduling participant ... (CFR), International Conference of Harmonisation (ICH) and Good Clinical (Research) Practice ( GCP ) Guidelines. Clinical Research Coordinator C:… more
- e CancerCare (Fresno, CA)
- …regulations and guidelines of the Food, Drug and Cosmetic Act; and accepted standards of Good Clinical Practice ( GCP ). Ensure that the physical ... department. Assures compliance with all regulatory requirements and standards of good practice ( GCP ) related to the conduct of clinical research.… more
- University of Colorado (Aurora, CO)
- …trials. **Knowledge, Skills, and Abilities:** + Knowledge and understanding of federal regulations and Good Clinical Practice ( GCP ). + Ability to ... Ensure protocol specific compliance and compliance with FDA, OHRP, GCP , IRB, HIPAA, UCD, and affiliates. + May be...result, we have seen tremendous and sustained growth. The clinical practice sites have built new hospitals,… more
- University of Pennsylvania (Philadelphia, PA)
- …centers, private practices, and research institutes, to ensure compliance with relevant regulations, Good Clinical practice ( GCP ), and FDA guidelines. ... wellness programs and resources, and much more. Posted Job Title Clinical Research Coordinator B (Regulatory Coordinator)(Department of Dermatology) Job Profile… more
- IQVIA (Durham, NC)
- …assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)- Good Clinical Practice ( GCP ), protocol), ... knowledge of applicable clinical research regulatory requirements ie, Good Clinical Practice ( GCP ) and International Conference on Harmonization… more
- Kelly Services (Tampa, FL)
- …* Oversee investigational staff and support appropriate training of the staff in compliance with Good Clinical Practice ( GCP ) with the protocol. 2. ... or verify formal approvals according to International Conference on Harmonization (ICH) Good Clinical Practice ( GCP )and any regional, state and federal… more
- University of Pennsylvania (Philadelphia, PA)
- …of study progress. + Maintain a working knowledge of relevant regulations and guidelines, such as Good Clinical Practice ( GCP ). + Perform other duties as ... of research methodology and clinical trial design. + Familiarity with Good Clinical Practice ( GCP ) guidelines, HIPAA, and applicable regulations. +… more
