- GE HealthCare (Chicago, IL)
- …This includes processing research proposals, reviewing budgets, making payment to investigator sites, and fulfilling requirements for documentation according to GE ... facility. **Job Description** + **Roles and Responsibilities** + Project manages Investigator Sponsored and GE Sponsored Research projects for the Molecular Imaging… more
- Pfizer (Groton, CT)
- …may leads or supports other critical documents, eg, protocol amendments, investigator brochure, and regulatory documents. + Collaborate with Clinical Operations to ... external experts, consultants, key opinion leaders, regulators and disease specific investigator networks to ensure implementation of latest clinical thinking and… more
- University of Utah (Salt Lake City, UT)
- …a critical role in the conduct of the study; assists the Principal Investigator (s) under supervision of the Research Manager in determining and accomplishing study ... correspondence. 3. Coordinates participant study visits and related facility, drug /device, and equipment availability. 4. Obtains informed consent and addresses… more
- University of Utah (Salt Lake City, UT)
- …join our multidisciplinary team devoted to melanoma. We seek an exceptional investigator whose research expertise complements our ongoing areas of excellence in ... (GEMMs and PDXs) and zebrafish, mechanisms and biomarkers of drug sensitivity/resistance, chemoprevention and clinical trials for melanoma as...of Dermatology in the tenure track and as an Investigator at HCI . Qualified individuals must have a… more
- Johns Hopkins University (Baltimore, MD)
- …prepares & submits required regulatory documents. + May participate in drug data sheet development/review/revision. + Monitors for IRB approval/request for further ... prior to initiation of research activity. + Represents department at research, investigator and protocol initiation meetings as required. + Assures that all elements… more
- Taiho Oncology (Pleasanton, CA)
- …documents such as study protocols and clinical study reports (CSRs), investigator brochures, DSUR, NDA/MAA registration documents and publications. + Reviews and ... be considered. Knowledge, Skills, and Abilities: + 3-5 years of experience in clinical drug development in pharmaceutical industry. + At least 2 years in drug … more
- Taiho Oncology (Pleasanton, CA)
- …relevant clinical documents of high quality, such as study protocol protocol(s), investigator brochure (IB), informed consent forms (ICF), case report forms (CRF), ... and Abilities: + Strong working knowledge of the US/EU drug development process required. + ≥ 8 years of...and/or industry, including experience as a medical monitor and (sub) investigator in oncology clinical trials. + ≥ 3 years… more
- Dana-Farber Cancer Institute (Brookline, MA)
- The Regulatory Coordinators (RC) works under the direction of the Principal Investigator (s), Clinical Research Manager and / or directly for the Clinical Trials ... Event reports, to the appropriate regulatory agencies including the Food and Drug Administration (FDA), Office of Biotechnology Activities (OBA), etc. + Prepares,… more
- Fresenius Medical Center (Columbus, MS)
- …and conduct of clinical trials under the direct supervision of the Principal Investigator (PI), Director, and other site personnel as applicable. Responsible for the ... evident and appropriately escalates to site manager, Director, and/or principal investigator for resolution as needed + Obtains and prepares regulatory/essential… more
- Organon & Co. (Jersey City, NJ)
- …dialogue and insights on the implementation of new medicines. + Investigator -Initiated Study management: Aid with review of Investigator -Initiated Study ... paid caregiver/parental and medical leave, and health benefits including medical, prescription drug , dental, and vision coverage in accordance with the terms and… more