- Novo Nordisk (West Lebanon, NH)
- …your career. Are you ready to realize your potential? The Position The Deviation Investigator -Writer is responsible for investigating and writing of deviations ... the technical merit and completeness according to regulatory expectations. The Deviation Investigator -Writer will be responsible for initiating investigations… more
- Curia (Albuquerque, NM)
- Quality Deviation Investigator II in Albuquerque, NM Summary: Curia provides global contract research and manufacturing services to the pharmaceutical and ... biotechnology industries. The Quality Deviation Investigator (QDI) II is responsible for...champion for quality priority principles and compliance within the Operations organization. This position reports directly to the Quality… more
- Lilly (Concord, NC)
- …area deviation and corrective action discussions as a lead investigator with a cross-functional team from Engineering, Maintenance, Technical Services / ... people around the world. **Responsibilities:** During the project phase, the Operations Associate (OA) will support commissioning, qualification, and validation of… more
- Bristol Myers Squibb (Summit, NJ)
- …of S12 CAR-T operations . The incumbent will be assigned more complex deviation investigations, and often need to create and facilitate teams to execute all ... elements in a timely manner. Deviation investigation includes execution of thorough root cause investigations, interviewing personnel, hypothesis testing and… more
- Bristol Myers Squibb (Devens, MA)
- …key stakeholders, such as Manufacturing Science and Technology, Quality, Manufacturing Operations , and Validation. **Major Duties & Job Responsibilities:** + Gain a ... at Devens Cell Therapy Facility (CTF) at Devens campus. + Act as a deviation author for deviations related to computerized systems (DeltaV, Syncade, PI, Benchtop IT… more
- IQVIA (Los Angeles, CA)
- Ensures safe and effective operations of clinical research studies. Safeguards the wellbeing of research subjects in a medical capacity; reviews study protocols; ... accordance with the Health and Safety policies. Serves as sub- Investigator for clinical research studies conducted by a supervising...the delivery of care to the volunteer Report any deviation from normal practice to senior staff. * Review… more
- University of Miami (Miami, FL)
- …of specific clinical research studies. This roleassists in the day-to-day operations of clinical research protocol implementation and carries out study coordination ... in the LEO (Lymphoma Epidemiology and Outcomes) protocol. Works with principal investigator to determine eligibility. 2. Retrieve required lab and tissue specimens… more
- Catalent Pharma Solutions (Bloomington, IN)
- …appropriate corrective and/or preventive actions (CAPA) to prevent reoccurrence. The Investigator assists Operations and Quality Assurance teams to determine ... the initial triage and RPN score of each assigned deviation investigation to ensure it aligns with the company...addressed. + Completes all investigation information into a comprehensive deviation report in a manner that clearly defines the… more
- System One (Basking Ridge, NJ)
- …of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard ... with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings. Collect information and coordinate with DS Regulatory Operations… more
- Dana-Farber Cancer Institute (Boston, MA)
- …Oncology (GI) department working under the direction of the Principal Investigator (s), Regulatory Operations Manager, and/or directly for the Clinical ... of assigned study monitoring and auditing visits with study coordinator, Investigator , DF/HCC QACT, Industry Sponsors, and third party auditors. **Clinical Trial… more
- University of Miami (Miami, FL)
- …department standard operating procedures, under the supervision of the Principal Investigator (Pl) and supervisor. The Clinical Research Data Specialist is ... to protocol requirements and department policy. + Compiles patient data for Investigator review to determine patient eligibility for protocol enrollment. + Maintains… more
- University of Pennsylvania (Philadelphia, PA)
- …Takeshita Lab is to independently coordinate the regulatory compliance and operations of research protocols including quantitative, qualitative, and mixed method ... forms, institutional forms, FDA forms, continuing review and modification forms, deviation and exception memos/reports, and adverse event reporting forms) via IRB… more
- University of Florida (Gainesville, FL)
- …of all components of research studies under the direction of the principal investigator and/or supervisor. The coordinator plays an active, expert level role in ... work with data within REDCap. Regulatory and IRB: Responsible for regulatory operations and associated administrative tasks related to assigned research studies: *… more