- 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 ... nutraceuticals via confection to enhance wellness for all consumers. The ** Site Deviation Investigator ** will be independently responsible for the efficient… 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 ... one of our top pharmaceutical clients. This is a first shift role, on- site Monday through Friday. This position will be supporting the growing technical services… more
- Merck (Annapolis, MD)
- …and perform risked-based audits + Activities may include GCP audits of investigator sites, suppliers, third party collaborations and due diligence activities. + In ... escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the QAL and TA Head. + Interfaces and… 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...May assist with research project budget development + Ensuring site compliance with all research protocols and regulatory requirements… 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
- ThermoFisher Scientific (Suwanee, GA)
- …to the study executive and independent safety committee if applicable; medical training of site staff at Investigator meetings; CRA training in new indications + ... clinical trial protocols while implementing the latest scientific information, contribute to site selection, contribute to review and approval of study protocols and… more
- University of Miami (Miami, FL)
- …Monitors, Clinical research Coordinators and PIs in the organization and preparation of Site Initiation Visits (SIV). Attend site disease group tumor board ... and as required per UM policy. Under the supervision of the Principal Investigator . Determine data to be collected and develop forms for collecting/summarizing data.… 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
- Lilly (Concord, NC)
- …area deviation and corrective action discussions as a lead investigator with a cross-functional team from Engineering, Maintenance, Technical Services / ... reliable supply of products to patients. + Lead the deviation process for the warehouse operations in collaboration with...Understand and influence the Material control strategy for the site . + Provide operational and project support for the… more
- IQVIA (Troy, NY)
- …Description **Job Title:** Clinical Research Coordinator **Work Set-Up:** Working On- site **Schedule** : 16 hours per week. **Responsibilities:** + **Phlebotomy** ... signs.** + Coordinate clinical research studies conducted by a supervising principal investigator . + Update and maintain skills, training, and knowledge of current… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …the Pharmaceutical Industry. This role is mainly responsible for completing deviation investigations, OOS/OOT and CAPA development related to EM and microbiological ... within timelines and budgets. Create and maintain relevant metrics for department/ site . + Spreadsheets and databases will be leveraged for departmental and… 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 ... Velos etc.) in a timely manner according to department SOPs.9. Participates in site initiation visits (SIV), monitoring visits and participates in site disease… 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 ... etc.) in a timely manner according to department SOPs. 9. P articipate s in site initiation visits (SIV), monitoring visits and particip ate s in site disease… 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 ... Velos etc.) in a timely manner according to department SOPs.9. Participates in site initiation visits (SIV), monitoring visits and participates in site disease… 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 ... Velos etc.) in a timely manner according to department SOPs. Participates in site initiation visits (SIV), monitoring visits and participates in site disease… more
- Lilly (Indianapolis, IN)
- …committees to address study-related questions. + Provide scientific input for site selection, investigator meetings, steering committees, and clinical trial ... + Lead completion of clinical trial documents including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports. +… more
- Taiho Oncology (Princeton, NJ)
- …relevant clinical documents of high quality, such as study protocol protocol(s), investigator brochure (IB), informed consent forms (ICF), case report forms (CRF), ... studies as outlined by the manager. + Attend study site initiation visits (SIV) and provides therapeutic area, compound,...(EDC) platform. + Review and participate in the protocol deviation meeting that will occur monthly or as needed.… more
- Teleflex (Minneapolis, MN)
- …in department systems and development initiatives including related trainings. * Support investigator meetings as needed. * Support Protocol Deviation and ... This individual has knowledge and experience managing study activities from site selection, start-up, to close-out with adherence to regulations, maintaining data… more
- Bristol Myers Squibb (Summit, NJ)
- …deviations and supports investigations / CAPA development + Qualified as a deviation investigator and completes assigned investigations timely + Completes change ... experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location....out the highest potential of each of our colleagues. **On- site Protocol** BMS has an occupancy structure that determines… more
- Lilly (Indianapolis, IN)
- …**Prepares and educates internal and external customers/business partners (including investigator site staff) on inspection management.** **Actively supports ... **Expert in corrective and preventative actions (CAPA) management. Ensure deviation /change management, root cause investigation and corrective/preventive actions are… more