- Monster (Vernon Hills, IL)
- Cignus Solutions LLC has openings for the position " Clinical Regulatory Specialist " with Master's degree in Any Analytical Science, Research Management or ... related in reviewing regulatory documents, including study materials and IRB binders, to...Reports to NDMS, PDF rendition, and Novstyle formatting. Ensure clinical trial registration SOPs are aligned with… more
- Merck & Co. (Lower Gwynedd, PA)
- …robotics, IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated ... systems, data insight tools, and other applications required during non- clinical and clinical bioanalytical testing.-Benchmarks current approaches/techniques to… more
- Merck & Co. (Lower Gwynedd, PA)
- …robotics, IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated ... (eg, neutralization assays) will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. -As the AdVAnce… more
- Merck & Co. (Lower Gwynedd, PA)
- …robotics, IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated ... will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. -As the AdVAnce facility will not be fully… more
- Merck & Co. (Lower Gwynedd, PA)
- …robotics, IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated ... (eg, neutralizing assays) will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. -As the AdVAnce… more
- Eisai, Inc (Pittsburgh, PA)
- …disease state, product prescribing information, approved promotional clinical trials , patient access to medication, and regulatory /compliance guidelines ... profile, we want to hear from you. The Senior Oncology Sales Specialist is responsible for meeting/exceeding sales goals through promoting Oncology therapeutic… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom ... in the treatment of multiple myeloma.Legend Biotech is seeking a QA Shop Floor Specialist as part of the Quality Operations team based in Raritan, New Jersey. Role… more
- Merck & Co. (Lower Gwynedd, PA)
- …robotics, IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated ... Job DescriptionJob Description-Sample Management Specialist (P3), Regulated Bioanalytics, Integrated Logistics & Sample...will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings.… more
- Tenethealth (Detroit, MI)
- …- Troy and six ambulatory sites. Summary DescriptionUnder the direction of the Clinical Manager, Respiratory Care and the Chief of Pediatric General Surgery, sets ... patient's condition to physicians and staff.Assesses patient status and performs " trials off" through close monitoring (ie, changing ventilator settings, temporarily… more
- University of Pennsylvania (Philadelphia, PA)
- …of health and wellness programs and resources, and much more. Posted Job Title Clinical Research Regulatory Specialist B (Abramson Cancer Center) Job Profile ... Title Clinical Research Regulatory Specialist B Job Description Summary The...-CC to participate in the coordination of Phase I-V clinical trials . Reporting to the Regulatory… more
- University of Pennsylvania (Philadelphia, PA)
- … Clinical Research Regulatory Affairs Specialist Job Profile Title Clinical Research Regulatory Specialist B Job Description Summary Regulatory ... in obtaining and maintaining institutional and governmental approval for clinical trials . These trials often...but not limited to Phase I-IV clinical trials . + Prepare and process all regulatory … more
- University of Pennsylvania (Philadelphia, PA)
- … Regulatory Specialist A (Abramson Cancer Center) Job Profile Title Clinical Research Regulatory Specialist A Job Description Summary The Abramson ... the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. Regulatory ...CV, clinical licensure, and profile information. The Regulatory Specialist A may also work in… 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
- Beth Israel Lahey Health (Boston, MA)
- …a job, you're making a difference in people's lives.** The Sr. Regulatory Specialist supports regulatory compliance for clinical research at Beth Israel ... preparation of consent forms to the IRB on all clinical trials (industry, cooperative groups and PI...deviations and submission of other study documents to support regulatory compliance. Troubleshoot processes and procedures when issues are… more
- BayCare Health System (Clearwater, FL)
- …that's built on a foundation of trust, dignity, respect, responsibility, and clinical excellence. **Title:** Research Regulatory Specialist **Facility:** ... ready + Maintain regulatory master files for industry & investigator initiated clinical trials + Aid in the development of protocol specific standard… more
- Caris Life Sciences (Phoenix, AZ)
- …yourself, Caris is where your impact begins.** **Position Summary** A Clinical Trial Specialist provides operational and regulatory support for the Caris ... Clinical Trial setting. + Candidates should have experience with clinical trial regulatory documentation or TMF. + Candidates should have a strong… more
- HonorHealth (AZ)
- …(CTMS), and familiarity with basic finance and accounting principles. The successful Clinical Trial Operations Specialist will support Research Program ... Research Administration, and the research staff. The tasks the Clinical Trial Operations Specialist must...closely with Principal Investigators, Clinical Program Leads, Regulatory , Finance, Clinical Trials Personnel,… more
- Huron Consulting Group (Van Buren, AR)
- …You'll have the opportunity to expand upon your working knowledge and experience with clinical trial regulation, and to develop strong skills in the variety of ... clinical research budgets + Experience in coverage analysis **Preferred:** Clinical Trial budget development & negotiation experience is highly desired… more
- Hackensack Meridian Health (Hackensack, 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 ... and overseeing clinical operations of all assigned clinical trials and participates in assessing, planning,...general supervision of the principal investigator responsible for the clinical trial (s) to which is assigned. **Education,… 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
