- Northeast Georgia Health System, Inc (Gainesville, GA)
- …of improving the health of our communities. About the Role:Job SummaryThe Research Regulatory Specialist performs a wide range of tasks essential to the ... submission, approval, and maintenance of required regulatory documents for conducting clinical research in...of high quality research within the department. Familiarity with clinical trials operations, finance, budgets, contracting and… more
- Piper Companies (Philadelphia, PA)
- …stage regulatory submissions to the FDA Maintains active IND and Clinical Trial applications.Experience submitted to the Center for Biologics Evaluation and ... Piper Companies is currently seeking a Regulatory Affairs Specialist , Cell & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an… more
- Option Care Health (Tallahassee, FL)
- …infusion services for a broad range of specialized therapies, as well as clinical trial services and special programs for pharmaceutical manufacturers. Joining ... reports directly to the Senior Manager of Quality, Regulatory and Education. The RN Quality Specialist ...is accountable and responsible for maintaining compliance of all clinical documentation processes. The RN specialist evaluates… more
- Stanford University (Stanford, CA)
- Clinical Trials Regulatory Specialist 2 **School of Medicine, Stanford, California, United States** Research Post Date Feb 16, 2024 Requisition # 100464 ... innovative clinical research to improve human health. SCCR seeks a mission-driven Clinical Trials Regulatory Specialist 2. You will work with a… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …the diversity and excellence of our academic community. **Description** JOB DESCRIPTION: + The Clinical Trials Regulatory Specialist I is an entry-level ... position supporting regulatory affairs in clinical trial research. + The primary focus... trial portfolio. + Duties include: + Assists regulatory team ( Regulatory Specialist II… more
- Emory Healthcare/Emory University (Decatur, GA)
- …The Regulatory Specialist II is an intermediate level position supporting regulatory affairs in clinical trial research. + Incumbents are responsible ... reports. + Establishes and maintains processes and monitors practices to ensure regulatory documentation involving clinical trials complies with… more
- Methodist Health System (Dallas, TX)
- … clinical , investigator initiated trials (IITs), and retrospective analysis of clinical data. The Regulatory Specialist will support the mission, ... requirements * Obtain and facilitate tracking of relevant regulatory documents for clinical trials ...trials assigned. * Assist in the development of clinical trial documents for signature of principal… more
- University of Pennsylvania (Philadelphia, PA)
- …Title Veeva Quality Assurance Specialist (Abramson Cancer Center) Job Profile Title Clinical Research Regulatory Specialist B Job Description Summary The ... is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and...CRU Regulatory Affairs Office seeks a full-time Regulatory Affairs Veeva Quality Assurance Specialist to… more
- Houston Methodist (Houston, TX)
- …event reports, safety reports, and notifies IRB of study closures. + Maintains the required regulatory files for all clinical trials to ensure regulatory ... and study specific protocols/plans and processes. The Regulatory Compliance Specialist position maintains documentation for clinical research studies, case… more
- Hackensack Meridian Health (Neptune, NJ)
- …Minimum of 2 years experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or at least 4 years related experience in the field ... for coordinating and overseeing clinical operations of all assigned clinical trials and participates in assessing, planning, implementing and compliant… more
- Merck (Rahway, NJ)
- …to patients. The key areas of focus include: (1) diversity in clinical trials , (2) clinical trial recruitment and (3) general education and awareness ... globe, timely completion of carefully designed clinical trials is critical to drug development. The Specialist...nternal and External) critical communications, focused on our global Clinical Trial efforts. **This role is responsible… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The Senior Associate Director, Clinical Trial Diversity supports the Clinical Development & Operations (CD&O) strategy for Diversity & ... Inclusion in clinical trials , focusing on the US. They...the development and execution of Diversity & Inclusion in clinical trial strategies, core processes and best… more
- Vitalief (New Brunswick, NJ)
- …activation; regulatory compliance, data management. and other clinical trial activities for solid tumor, high enrollment, ... Join us and help clients adapt to evolving requirements in the research and clinical trial industry with cutting-edge solutions. Reasons to Work for Vitalief: +… more
- University of Colorado (Aurora, CO)
- …Team (CReST) has an opening for a full-time Clinical Research Startup Specialist to provide regulatory and operationalization startup support for a variety ... communicates with these entities in order to operationalize complex clinical trials . + Develops standard operating procedures... Clinical Practice, applicable regulations, and of the clinical trial lifecycle is essential. We are… more
- UCLA Health (Santa Monica, CA)
- Description The Division of Hematology-Oncology is seeking an experienced Senior Clinical Trial Specialist to join our team. In this role you will be ... the liaison for the site management and monitoring of clinical trials in Santa Monica. Responsible for...conduct Site Initiation Visits and Interim Monitoring Visits with clinical trial sponsor representatives; you will also… more
- Beth Israel Lahey Health (Boston, MA)
- …Type:** Regular **Scheduled Hours:** 40 **Work Shift:** Day (United States of America) The Clinical Trials Specialist II is responsible for fostering and ... to ensure disease groups have appropriate internal organization to effectively comply with regulatory requirements for clinical trials . Serves to provide… more
- Rockefeller University (New York, NY)
- …see the hospital website at: http://www.rucares.org/ Overview The Clinical Research Specialist serves as a regulatory expert and resource for investigators ... and new investigator audits, tracks deviations for early intervention, and supports clinical trial registration in Good Clinical Practice (GCP)… more
- Dignity Health (Phoenix, AZ)
- …Manages the daily operation and supervision of the Clinical Research Regulatory Affairs area and program specialist (s) in accordance with all applicable ... initiation and monitoring visits performed by pharmaceutical and device manufacturing clinical trial sponsors. Responsibilities Include: + Manages all functions… more
- Rush University Medical Center (Chicago, IL)
- …and accurate coverage analyses with budget overlay in a timely manner. * Review clinical trial protocols and related regulatory documents in order to ... PM) **Summary:** This position will create coverage analyses in accordance with Medicare's Clinical Trial Policy (NCD 310.1) and assist research staff within the… more
- Rush University Medical Center (Chicago, IL)
- …and accurate coverage analyses with budget overlay in a timely manner. * Review clinical trial protocols and related regulatory documents to prepare a ... - 4:30:00 PM) **Summary:** Reporting to the Director/Manager of Clinical Trials Research Revenue Cycle, this position...position will create coverage analyses in accordance with Medicare's Clinical Trial Policy (NCD 310.1) and assist… more
