- 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
- 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
- Johns Hopkins University (Baltimore, MD)
- …+ Requires minimum of one year of management experience. + Requires experience in clinical research and regulatory affairs. + Experience in protocol and ... The position requires strong project management and organizational skills, knowledge of clinical research regulations and grant processes, and the ability to… more
- Amgen (Washington, DC)
- …million patients worldwide. It's time for a career you can be proud of. ** Clinical Research Sr Medical Scientist, Endocrinology** **Live** **What you will do** ... commercial input into the development program. Participate and provide clinical input into safety and regulatory interactions.... Clinical Scientists or GDL and identify new clinical research opportunities. **Win** **What we expect… 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
- University of Maryland, Baltimore (Baltimore, MD)
- …Candidates with experience in developing and managing research teams, and in regulatory aspects of clinical trials are highly desirable. The candidates' ... or non-tenured faculty members at the Assistant Professor or Associate Professor rank. We are interested in MD, MD/PhD,...developing and managing research teams, and in regulatory aspects of clinical trials are highly… more
- University of Maryland, Baltimore (Baltimore, MD)
- …biologics regulatory science, including: Chemistry, Manufacturing, and Controls (CMC); Clinical Research ; Pharmacovigilance; Phase IV Research (eg, ... position of Instructor (non-tenure track) for the MS in Regulatory Science within the Department of Pharmaceutical Sciences. The...as well as another aspect of the program (eg clinical research ). * Create, facilitate, interact, and… 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
- Guidehouse (Bethesda, MD)
- …and secure handling of the patient's medical records. + Knowledge of federal regulatory requirements pertaining to clinical research + Knowledge of ... National Institutes of Health (NIH). This is primarily a clinical research role that will ensure human...+ Participates in the preparation of reports for appropriate regulatory agencies and monitoring bodies or boards. + Assists… more
- Amgen (Washington, DC)
- …and technical Regulatory guidance relating to Amgen products. + Perform regulatory research to acquire relevant histories, precedence and other information ... regulatory strategies. **Responsibilities:** + Implement the US regulatory plan and obtain and maintain Clinical ...**Or** Bachelor's degree and 6 years of experience in regulatory or pharmaceutical drug development **Or** Associate 's… more
- Johns Hopkins University (Baltimore, MD)
- …to all protocol and regulatory requirements to ensure the validity of the clinical research data. + Works directly with the principal investigators, Sr. ... **_Research Program Coordinator_** who will be responsible for coordinating clinical trials and other research projects in...Research Associate , and other study team members… 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
- University of Maryland, Baltimore (Baltimore, MD)
- …School Pharmacy is conducting an open rank search for a School Assistant, Associate , or Full Professor in the Department of Practice, Sciences, and Health Outcomes ... Research . The position is a full-time, non-tenure-track, 12-month appointment based at the Baltimore, Maryland Campus. This position requires teaching; service to… 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