- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Investigator Compliance Specialist as part of the Technical Operations team based in ... Raritan, NJ. Role OverviewThe CAR-T Compliance Auditor (Sr. Investigator ) will be a key member of the Technical Operations team, responsible for ensuring adherence… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Interventional, Non-Interventional, Managed Access Programs, and Investigator -Initiated Studies.Provide comprehensive quality oversight for Medical Affairs ... stakeholders to uphold the ethical conduct of interventional, non-interventional, investigator -initiated trials, and managed access programs to the highest quality… more
- PDS Tech Commercial, Inc. (Indianapolis, IN)
- **Now Hiring: Process Expert Deviation Investigator | Onsite in Indianapolis** _Pay: $30 - $40/hour (based on skills and qualifications) | Monday-Friday, 8:00 AM ... global leader in pharmaceutical manufacturing, is seeking a **Process Expert Deviation Investigator ** to join their team in Indianapolis. This critical role… more
- Actalent (Greenville, NC)
- Job Title: Manufacturing Investigator Job Description The Deviation Investigator is tasked with identifying, documenting, investigating, and resolving ... records of all deviations, investigations, and corrective actions. + Present deviation reports to management and regulatory authorities as required. + Ensure… more
- Actalent (Allendale, NJ)
- Job Title: QA Investigator Job Description We are seeking a dedicated QA Investigator to join our team. The role involves writing and completing investigations ... and use of root cause analysis tools, discrepancy, and deviation processes. + Champion CAPA plans and implementation. +...with cell and gene therapy. Work Environment The QA Investigator will work closely with quality assurance and a… more
- Kelly Services (Cincinnati, OH)
- **_Experienced in Deviation Remediation?_** **Lead Pharma Investigations in a 6-12 month Contract Role w/ Benefits - Apply Now!** **Now Hiring:** Lead Investigators ... - Pharma Manufacturing ( Deviation Management) **Location:** Cincinnati, OH (onsite) **Duration:** 6-month contract **Pay Rate:** $40-45/hour + benefits Kelly… 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
- 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
- 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
- Dana-Farber Cancer Institute (Brookline, MA)
- The Regulatory Coordinators (RC) works under the direction of the Principal Investigator (s), Clinical Research Manager and / or directly for the Clinical Trials ... Core with other required hard copy submissions to FDA, yearly Principal Investigator Worksheet (PIW) updates for DFCI physicians participating in National Cancer… more
- Ohio University (Athens, OH)
- …studies include both sponsored clinical trials (Phases I-IV) and investigator -initiated research studies (qualitative and quantitative) conducted through the Ohio ... ) for review and approval (ie initial, continuing review, deviation , AE/ SAE , close-out, etc.) + May assist...data per HIPAA and CTRU standards and study Principal Investigator and/or sponsor standards + Maintaining regulatory documents in… more
- Lilly (Concord, NC)
- …area deviation and corrective action discussions as a lead investigator with a cross-functional team from Engineering, Maintenance, Technical Services / ... methodologies and mindset - lean, six sigma, etc. + Documentation, deviation and change management systems (eg, Trackwise. Veeva QualityDocs, Kneat) **Additional… more
- ThermoFisher Scientific (Alachua, FL)
- …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
- 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
- IQVIA (Boca Raton, FL)
- …signs.** + Coordinate clinical research studies conducted by a supervising principal investigator . + Update and maintain skills, training, and knowledge of current ... delivery of care to the volunteer. + Report any deviation from normal practice to senior staff. **Support Study...case report forms (CRFs). Collaborating closely with the study investigator , informing on relevant adverse events and serious adverse… more
- University of Pennsylvania (Philadelphia, PA)
- …Coordinator to organize, coordinate and implement different phases of investigator -initiated and industry-sponsored clinical trials of novel therapies or currently ... testing; within the EMR or other tools + Attend Investigator Initiation meetings + Obtain slides from pathology and...by sponsor or CRO (institutional forms, FDA Form 1572, deviation memos, physicians and coordinators' CVs and medical licenses,… more
- Dana-Farber Cancer Institute (Brookline, MA)
- The Regulatory Coordinators (RC) works under the direction of the Principal Investigator (s), Clinical Research Manager and / or directly for the Clinical Trials ... of assigned study monitoring and auditing visits with study coordinator, Investigator , DF/HCC QACT, Industry Sponsors, and third party auditors. + **Clinical… 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. + Compile s patient data for Investigator review to determine patient eligibility for protocol enrollment. + Maintain s… 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. ... study specified treatment, follow-up visits and procedures + Meet with Principal Investigator routinely to discuss study related issues and to ensure completion of… more
