- Catalent Pharma Solutions (Greendale, IN)
- **Site Deviation Investigator ** **Position Summary** + **Work Schedule:** Monday to Friday, business hours + 100% on-site in Greendale, IN Greendale is one of ... nutraceuticals via confection to enhance wellness for all consumers. The **Site Deviation Investigator ** will be independently responsible for the efficient and… more
- ThermoFisher Scientific (St. Louis, MO)
- …management systems **A day in the Life:** . Manage Major deviation investigations, including assembling investigation teams, leading root cause analysis, development ... and documentation (TrackWise, Master Control, or equivalent) * Experience in deviation investigations, CAPA, change control, and root cause analysis * Proficient… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …crucial direction of the Head of Operations and the Head of Quality Systems, the Deviation Investigator will play a pivotal role in our company's growth by ... owning and investigating all Manufacturing-related deviations. The Deviation Investigator will collaborate with cross-functional stakeholders to perform simple… more
- Astrix Technology (Springfield, MO)
- …and compliant closure. + Provide coaching and training to staff on deviation investigations, RCA methodologies, and investigator qualification. + Perform and ... leading global CDMO, is looking to hire a QC Deviation Specialist III to join their growing team in...4-month contract (possibility of extension) **Position Summary** The QC Deviation Specialist III will be responsible for leading and… more
- Takeda Pharmaceuticals (Round Lake Beach, IL)
- …of my knowledge. **Job Description** **About the role:** The Lead Investigator will initiate and execute deviations in support of Manufacturing. Responsibilities ... improve quality, and provide new product support, as needed. Lead or support Deviation Free Initiatives + Work closely with other QA departments and manufacturing… more
- Insight Global (Boston, MA)
- Job Description Insight Global is looking for a QC Analytical Investigator to sit on-site at a brand new facility in the beautiful Seaport district of Boston ... with previous experience authoring, reviewing and editing risk assessment, CAPA and deviation documents . Effective communicator with ability to influence a group of… more
- University of Washington (Seattle, WA)
- …Office (RSO) to meet all regulatory and compliance submissions involving editing of investigator initiated protocols and consent forms as well as submission of NCI ... **Duties:** 65% Guide MDs with all aspects of the development of investigator initiated studies. Where required, assist MDs with retrospective chart review studies… more
- Amgen (Holly Springs, NC)
- …EHSS, and Quality. This position is responsible for ensuring deviation investigations are successfully conducted and documented while driving improvements ... in the investigation process. + Manage Major deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs,… more
- ThermoFisher Scientific (Austin, TX)
- …expertise, experience and training. Working under the direction of the chief physician/ investigator and the Staff Paramedic in the Clinic, ensures subject safety, ... documenting, and treating AEs, or directly deferring to the physician/ investigator as needed. **Essential Functions and Other Job Information:** **Essential… more
- Dana-Farber Cancer Institute (Boston, MA)
- …research coordinators and independently manages a portfolio of projects for each investigator . The specific tasks and responsibilities of the TRPM I vary based ... on departmental and investigator needs. This position's work location is onsite at...in meeting regulatory requirements, including protocol submissions, amendments, and deviation filings. This ensures that all research activities complies… more
- University of Pennsylvania (Philadelphia, PA)
- …proposals, and research related presentations. Works closely with the Principal Investigator , manager, and study team to identify problems and develop solutions. ... needed and monitor results. Responsible for study coordination for investigator -initiated studies, multi-center research studies, and patient-oriented clinical and… more
- Kelly Services (West Point, PA)
- …values + Prepares scientific slides, attends and presents protocol information at Investigator Meeting + Scientific lead on Clinical Trial Team (CTT) + Reviews ... Supports publications/presentations as needed + Reconciles and review all protocol deviation classifications in SPECTRUM + Assesses and prepares protocol … more
- ThermoFisher Scientific (Suwanee, GA)
- …Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions and other clinical documents as required for the conduct of ... committee if applicable; medical training of site staff at Investigator meetings; CRA training in new indications + Ensure...to questions from sites /IRBs RAs, eligibility and protocol deviation decisions will be harmonized across medics **Keys to… more
- Dana-Farber Cancer Institute (Boston, MA)
- …with each TRPM managing a separate portfolio of projects for each investigator . Specific tasks and responsibilities are varied and dependent on the needs ... completion, to meet research objectives. + Grant Support: Assist the Principal Investigator (PI) with grant applications and progress reports, playing a crucial role… more
- Dana-Farber Cancer Institute (Boston, MA)
- …(RC) works under the direction of the Breast Oncology Principal Investigator (s), Regulatory Operations Manager, Clinical Research Manager and / or directly ... of assigned study monitoring and auditing visits with study coordinator, Investigator , DF/HCC ODQ, Industry Sponsors, and third-party auditors + Track and… more
- J&J Family of Companies (Spring House, PA)
- …+ Adheres to finance reporting deliverables and timelines. + Attends/participates in Investigator Meetings as needed. + May schedule and conduct a local/country ... investigator meeting. + Will be expected to present and...issues and/or trends across a trial project and escalates deviation issues to the TDM/TDL and FM as needed.… more
- University of Miami (Miami, FL)
- …department standard operating procedures, under the supervision of the Principal Investigator (PI) and supervisor. The Clinical Research Data Specialist is ... UM and department policies and procedures.13. Compiles patient data for Investigator review to determine patient eligibility for protocol enrollment.14. Maintains… more
- University of Miami (Miami, FL)
- …department standard operating procedures, under the supervision of the Principal Investigator (PI) and supervisor. The Clinical Research Data Specialist is ... UM and department policies and procedures. Compiles patient data for Investigator review to determine patient eligibility for protocol enrollment. Maintains… more
- University of Miami (Plantation, FL)
- …standard operating p rocedures , under the supervisio n of the Principal Investigator (PI) and supervisor . The Clinical Research Data Specialist is responsible for ... and department policies and procedures. 13. Compile s patient data for Investigator review to determine patient eligibility for protocol enrollment. 14. Maintain s… more
- University of Miami (Miami, FL)
- …standards and clinical credentials as delegated by the Principal Investigator . 6. Monitors, documents, reports, and follows-up on study unanticipated/adverse ... in implementing protocol amendments under direct supervision of the Principal Investigator . 8. Assists with study orientation and protocol related in-services to… more