- Aequor (San Diego, CA)
- …complex medical-scientific data from a broad range of disciplines (eg, clinical trial laboratory data, nonclinical data, postmarketing reports, scientific ... of certain post-marketing commitments and ensuring compliance with global regulatory requirements.Position Summary / ObjectiveAppropriately perform core signal detection… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …inspection/release of materials related to manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP ... of multiple myeloma. Legend Biotech is seeking a QA Warehouse Incoming Raw Material Specialist as part of the Quality team based in Raritan, NJ. Role Overview The… more
- EY (New York, NY)
- …personalities Strong verbal and written communication skillsAbility to learn the science and clinical trial data on brands you'll be responsible for working ... with the highest quality as possibleCollaborate with the MLR specialist to make sure the assets are ready for...manage the team to adhere to the Medical, Legal, Regulatory (MLR) review process for promotional contentExperience meeting tight… 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 (Nutley, 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
- 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
- ThermoFisher Scientific (Greenville, NC)
- …a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of ... research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver... clinical research services provide end-to-end support for clinical trials from study start up to… more
- Actalent (Basking Ridge, NJ)
- …Specialist supports Clinical Study Leads on overall execution of global clinical trials (both internally sourced studies and studies outsourced to CROs). ... plan + Monitors and updates investigator/site status for the trial , and supports with clinical trial...level is ok with 4+ years 2+ years of clinical trials experience (Pharma experience preferred) 2+… 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
- University of Pennsylvania (Philadelphia, PA)
- …Prepare any necessary regulatory documentation DUTIES: The Clinical Trials , Billing, Budget and Compliance Specialist will report directly to the ... and much more. Posted Job Title Clinical Trials , Billing, Budget and Compliance Specialist Job Profile Title Financial Analyst Job Description Summary Job… 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
- Houston Methodist (Houston, TX)
- …accurate data collection, documentation organization, and safety of study volunteers. Ensures accurate regulatory filing + Assists Clinical Trial Manager in ... is responsible for supporting multiple projects under supervision of Clinical Trial Manager which may include ...from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research… 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
- 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
