- 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 Director,… more
- Curia (Albuquerque, NM)
- Quality Deviation Investigator III in Albuquerque, NM Summary: The Quality Deviation Investigator III plays a crucial role in overseeing and executing ... and thoroughness in all reporting. In this senior-level position, the Investigator collaborates with cross-functional teams to collect and analyze critical data… more
- Merck (West Point, PA)
- **Job Description** We are seeking a Growth and Improvement minded Deviation Management investigator that can help drive our Strategic Operating Priorities. + ... Us **Summary** As part of our Manufacturing Division, Polysaccharide Vaccines Technical Operations at West Point is seeking a highly motivated individual to partner… more
- Actalent (Parsippany, NJ)
- Job Title: Compliance InvestigatorJob Description We are seeking a skilled Compliance Investigator to join our team. In this role, you will be responsible for ... writing and completing investigations and deviations from a compliance and operations perspective. You will review investigations to ensure manufacturing and GMP… more
- University of Washington (Seattle, WA)
- …and National Cancer Institute (NCI) Independently, process and coordinate the operations of research studies. This requires the knowledge and skills specific ... Office (RSO) to meet all regulatory and compliance submissions involving editing of investigator initiated protocols and consent forms as well as submission of NCI… more
- Lilly (Plainfield, IN)
- …to make life better for people around the world. The Senior Operations Associate supports the North American Logistics Operation (NALO) organization, reporting to ... the Associate Director of Operations for NALO. The role primarily supports internal US...events and drive implementation of appropriate countermeasures (Trackwise Lead Investigator and Change Owner). + Ensure appropriate training curricula… more
- Dana-Farber Cancer Institute (Boston, MA)
- The Assistant Regulatory Operations Manager (AROM) is a newly created position and will be responsible for aiding in oversight of the Leukemia disease group's ... (institutional review board) contacts, clinical trial sponsors, DFCI-designated Principal Investigator (PI) and the disease-group Clinical Research Manager to… 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
- 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
- Daiichi Sankyo Inc. (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 ... meetings with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings. Support Fair Market Value process in evaluating study budgets… 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
- Dana-Farber Cancer Institute (Brookline, MA)
- The Regulatory Coordinators (RC) works under the direction of the Principal Investigator (s), Regulatory Operations Manager, Clinical Research Manager and / or ... of assigned study monitoring and auditing visits with study coordinator, Investigator , DF/HCC ODQ, Industry Sponsors, and third-party auditors. **Clinical Trial… more
- United Therapeutics (Silver Spring, MD)
- …regulatory agency and other audits/inspections of Unither Bioengineering and prepare investigator sites for FDA or other regulatory agency inspections + Actively ... collaborate with other functional areas and investigator sites to prepare viable audit responses and evaluate the adequacy of corrective actions + Consult, review… more
- Amgen (Holly Springs, NC)
- …with traditional stainless steel equipment to allow for maximum flexibility in operations . The FleX Batch facility will not only feature the best in-class ... when necessary. The flexibility to support all four shifts covering 24/7 operations is a requirement. + Supporting the development and execution of the… 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
- Federal Reserve Bank (San Francisco, CA)
- …but not limited to audit, risk management, or business line operations . Existing examiner commissioning is helpful but not required. **Essential Responsibilities:** ... reporting, and control; vendor and third party risk management; and continuity of operations . You will work closely in a collaborative manner with a variety of… more
- Kelly Services (Seattle, WA)
- …product deviation reporting, lot distribution reports, IND safety reports, clinical/ investigator documentation, or other reports, as needed. + May or may not ... writing, and tracking timelines. + Works with technical departments in R&D/ Operations /Quality to develop high quality submissions. + Prepares and manages submissions… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …reviewing study participant eligibility, protocol interpretation, coding support, protocol deviation review, and data cleaning in collaboration with Clinical ... Operations and Data Management 5. Work with Biometrics to...of regulatory documents including, IND submissions, annual updates, DSUR, investigator brochures, and briefing documents 2. Study specific documents… more