- Dana-Farber Cancer Institute (Boston, MA)
- …Regulatory Coordinators (RC) works under the direction of the Principal Investigator(s), Regulatory Operations Manager, and Clinical Research Manager to ... complete the regulatory requirements of the Leukemia clinical research project. The RC coordinates aspects of protocol submissions, prepares and submits … more
- Bayer (Cambridge, MA)
- …with diagnostic co-development partners and leads the development of diagnostic regulatory strategy in multiple projects in clinical development and ... for approval); + Advise on IVD/CDx strategies on optimal regulatory pathway (exploratory vs. patient selection for clinical...Bayer Case Studies Design, prepare and implement training programs. ** Monitor key changes in the global regulatory … more
- Dana-Farber Cancer Institute (Brookline, MA)
- …of current regulations, regulatory guidance and or local policies + Assists Clinical research Manager with regulatory based training and implementation ... the Principal Investigator(s), and will directly report into the Clinical Trials Office to complete the regulatory ...trials across conducted across several disease groups. of the clinical research project. The RC coordinates aspects… more
- Abbott (Sylmar, CA)
- … regulatory guidelines, policies and regulations + Ethical guidelines of the regulatory profession, clinical research and regulatory process ... processes, procedures + Provide regulatory input to product lifecycle planning + Monitor regulatory outcomes of initial product concepts and provide input to… more
- Guthrie (Sayre, PA)
- …executive has broad oversight responsibilities across core domains: + Clinical Research Operations in compliance and in regulatory areas. + Supports ... MBA, or MS in STEM discipline). + Minimum 3-5 years of direct experience in clinical or pharmaceutical-sponsored research or regulatory fields such as the… more
- Johns Hopkins University (Baltimore, MD)
- …organizing study report forms and regulatory binders. + Screen potential research subjects for participation in a randomized clinical trial; evaluate ongoing ... clinical trial involving adolescents ages 12-17, including parents and clinical providers. + Will comply with all regulatory /IRB guidelines including… more
- Dartmouth Health (Lebanon, NH)
- Overview THIS POSITION WILL SIT ON SITE IN ST. JOHNSBURY LOCATION Clinical Research Coordinator II performs a full range of clinical research duties at a ... skilled level and has a working knowledge of the clinical research process and the regulations that...all of aspects of the study operations (including subject management/ regulatory ) with oversight from the investigator or their designee.… more
- Dartmouth Health (Lebanon, NH)
- …practices, the ethical conduct of research and a full range of clinical research duties including regulatory compliance. * May arrange/schedule required ... Overview The Clinical Research Coordinator III performs a...Independently executes all aspects of the study operations (subject management/ regulatory ) with minimal oversight from the investigator or their… more
- Ascendis Pharma (Palo Alto, CA)
- …a proven ability to partner effectively with multiple functions, including Clinical development, Research , Product Development, Medical Affairs, Commercial and ... Provide regulatory assessments of product opportunities and threats + Monitor the competitive environment to sustain expertise in therapeutic area treatment… more
- Saint Luke's (Kansas City, MO)
- …regulations and guidance, and HIPAA, 21 CFR Part 11, and GDPR requirements related to research + Knowledge of clinical research procedures, clinical ... Partner who will assist in the overall management of regulatory compliance for the Research Program at... and terminology, and the essential documents related to clinical research studies + Ability to communicate… more