- The George Washington University (Washington, DC)
- …Dr. Jie Luo is seeking an experienced candidate at the rank of Senior Research Associate . This position will independently carry out research /development ... and developing antigen-specific immunosuppressive therapies for the disease. The research is highly interdisciplinary, relying on tools from molecular biology,… more
- The George Washington University (Washington, DC)
- …Summary: The Director, Regulatory Oversight position reports to the Associate Provost Research Integrity and Compliance (AP-RIC) and is responsible ... with Office of Research Integrity and Compliance leadership, the Office of Clinical Research (OCR) staff, Environmental Health and Safety, Office of General… more
- Kelly Services (Washington, DC)
- …take the next step in your career, trust The Experts at Hiring Experts. The Sr. Clinical Research Associate is responsible for in the execution of ... protocol, monitoring plan, case report forms, etc.). + Remain current on clinical trial regulatory requirements and guidelines (eg GCP, ICH, FDA, etc) with the… more
- Guidehouse (Bethesda, MD)
- …currently searching for a Clinical Research Protocol Navigator to provide clinical research regulatory support through the NINDS Clinical Trials ... Clinical Research Coordinator (CCRC); Certified Clinical Research Associate (CCRA) +...and operational procedures. + Collect, distribute, file, and submit regulatory documents. + Review clinical research… more
- Guidehouse (Bethesda, MD)
- …Navigator. The primary role for this Protocol Navigator (PN) position is to provide clinical research regulatory support through the NINDS Clinical ... + Develop new and review completed clinical research informed consent and other ethics and regulatory...Clinical Research Coordinator (CCRC), or Certified Clinical Research Associate (CCRA) preferred.… more
- GAP Solutions Inc (Bethesda, MD)
- … Research Coordinator (CCRC). + Certified Clinical Research Associate (CCRA). + Experience liaising with regulatory authorities. + Experience with ... The primary role for this Protocol Navigator (PN) position is to provide clinical research regulatory support through the NINDS Clinical Trials Unit… more
- Georgetown Univerisity (Washington, DC)
- …interested in intellectual inquiry and making a difference in the world. Requirements Clinical Research Coordinator 2 - Department of Neurology - Georgetown ... University Medical Center The Clinical Research Coordinator 2 (CRC2) manages and...On a daily basis, the CRC2 reports to the Associate Director of Clinical Trials, and is… more
- GAP Solutions Inc (Rockville, MD)
- …experience plus a Bachelor's degree is equivalent to a Ph.D. + Certified Clinical Research Associate (CCRA). + Experience identifying, evaluating, and ... trials in order to ensure data quality and compliance with regulatory requirements for clinical research . + Provide feedback to CTOBB staff as requested… more
- Guidehouse (Rockville, MD)
- …in Microsoft Office Suite **What Would Be Nice To Have** **:** + Certified Clinical Research Associate (CCRA) preferred. + Previous experience with the ... trials in order to ensure data quality and compliance with regulatory requirements for clinical research . + Provide feedback to CTOBB staff as requested… more
- Alaka'ina Foundation Family of Companies (Silver Spring, MD)
- …(GCP) and Human Subjects Protection (HSP) DESIRED SKILLS AND EXPERIENCE: + Certified Clinical Research Associate (CCRA) + DoD experience REQUIRED CITIZENSHIP ... REQUIRED SKILLS AND EXPERIENCE: + Knowledge and experience in the areas of clinical research and regulatory affairs as related to clinical studies,… more
- Amgen (Washington, DC)
- …research and scientific experience Or + Bachelor's degree and 8 years of related research and scientific experience Or + Associate 's degree and 10 years of ... time for a career you can be proud of. ** Regulatory Real World Evidence (RWE), Manager** **Live** **What you...for observational studies and for studies combining RWD and clinical trial data + Provide support to therapeutic area… more
- Merck (Rockville, MD)
- …Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. ... **Job Description** Our Regulatory Affairs team bring new medical advancements to...not limited to:** + Reports to Executive Director or Associate Vice President, Therapeutic Area Lead. + Develops worldwide… more
- Merck (Rockville, MD)
- …Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. ... not limited to:** + Reports to Executive Director or Associate Vice President, General Medicine + Develops worldwide product...to facilitate initial approval by agencies for conduct of clinical trials + Participate in regulatory due… more
- Amgen (Washington, DC)
- …Key responsibilities include: + Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, ... drug applications/biologics license applications is strongly preferred + Experience with regulatory documents in Regulatory Affairs, Research , Development… more
- Amgen (Washington, DC)
- …across the drug development and commercialization lifecycle. The data we produce informs clinical trial design, supports regulatory decision making and aids in ... for a career you can be proud of. **Observational Research Senior Manager** **Live** **What you will do** Are...and effectiveness of an Amgen medicine to inform a regulatory decision (eg, label expansion/change) and fulfill a global… more
- Alaka'ina Foundation Family of Companies (Silver Spring, MD)
- …Positions to Include: + + Laboratory Research Associate + Animal Behavior Research Assistant + Clinical Research Coordinator I & II REQUIRED SKILLS ... and update all applicable regulatory files and documentation for all regulatory guidelines for human and animal research , including appropriate institutional… more
- Amgen (Washington, DC)
- …world. In this vital role you will report to the Therapeutic Area Quality Lead - Clinical Quality, Clinical & Research Quality (CRQ). The Senior Manager, ... clinical trial lifecycle (protocol development, database lock, and regulatory submissions/ approvals). You will play a vital role...and quality by design are a core responsibility. Or Associate 's degree and 10 years of **Quality Management** ,… more
- Amgen (Washington, DC)
- …of clinical research experience OR Bachelor's degree and 7 years of clinical research experience OR Associate 's degree and 12 years of clinical ... medical monitoring and management of oncology phase 1 collaborators, consultants, and/or Clinical Research Organizations in completion of key projects +… more
- Merck (Washington, DC)
- … expectations for small molecules and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), ... clinical trial applications (CTDs)), and representing QP2-IO at regulatory meetings. **Minimum education required:** + Ph.D. with 1-3 years of pharmaceutical… more
- Amgen (Washington, DC)
- …and instructs others in statistical areas relating to randomized and non-randomized clinical research + Strong analytical and problem-solving skills + Proficient ... for a career you can be proud of. Biostatistics Associate Director **Live** **What you will do** Let's do...Nephrology, and Neuroscience), ensuring that the statistical aspects of clinical activities meet required standards and are robust and… more
