program and schedule Conduct audits per plan while also leveraging QA colleagues and external resources as required Manage...: Experience with training clinical study teams, study designers, clinical sites, and at investigator meetings. Knowledge of QMS...
and provide QA/QC on field documentation and paperwork. Oversees work performed by field and laboratory technicians under the... direction of a Principal Investigator or Senior Archaeologist Over time, this position will come with opportunities to manage...
between the department and the investigator/inspector/assessor. Reviews charts, tables, etc. to analyze metrics (quality... in QMS, QA, QC, or Quality Auditing preferably in an environment such as blood banking, pharmaceutical, medical devices...
protocols, protocol amendments, investigator brochures, synopses, Clinical Study Reports, regulatory documents such as INDs... Prepares, edits, and finalizes protocols, investigator brochures, synopses, Clinical Study Reports, pre-IND, IND, NDA...
, Quality Assurance - GxP (GCP) is responsible for managing GxP Quality Assurance (QA) functions with an emphasis on Good... and/or conduct internal and external GCP audits of investigator sites, vendors, clinical study reports, investigator brochures...
/ Principal Investigator to work in our Austin, TX office under the direction of the Archeology Team Leader. This is a full-time... to our program. As a Project Archeologist / Principal Investigator, you will work closely with our Archeology Team Lead...
maintenance, lead investigator, and laboratory information management system (LIMS) administration. These functions directly... immediate actions in conjunction with QA and department management upon identification of a non-conformance Interview Subject...
within the Quality Control department include technical data review, training, instrument maintenance, lead investigator... in Trackwise to include but not limited to: Coordinate immediate actions in conjunction with QA and department management upon...
study drug materials according to practice standards and clinical credentials as delegated by the Principal Investigator... in implementing protocol amendments under direct supervision of the Principal Investigator. Assists with study orientation...
! JOB SUMMARY Works under the direction of an Investigator(s) with general supervision, to provide ongoing data management.... Maintains existing databases and ensures data integrity. Performs QA/QC clinical analysis and data checks using various...
maintenance, lead investigator, and laboratory information management system (LIMS) administration. These functions directly... immediate actions in conjunction with QA and department management upon identification of a non-conformance Interview Subject...
-functionally to assess deviation impact and identify root causes. Work with Scheduling and QA to ensure that batches... position. Coach new investigators as part of the Investigator Certification Program. Audit Support: Maintain...
and local regulations, requirements, and guidelines. Partners with quality assurance (QA) teams and other functional groups... Manage and track Development Operations internal and external audit responses. Support input and the review of investigator...
., Clinical Development, Pharmacokinetics, Quantitative Sciences, Regulatory, QA, Finance, Legal, etc.) to achieve clinical study... to travel (~25%). Experience working with cooperative group studies and investigator-sponsored trials is preferred. Experience...
effective operation of research protocols in collaboration with the principal investigator, study sponsor and protocol... and studies. · In collaboration with the Principal Investigator (PI), responsible for ensuring the informed consent...
Perform regular reviews of data according to data review/monitoring guidelines (CTMS, EDC, IVRS etc.) Work with QA for CAPA..., Data management, QA and QC, CRO, vendors etc.)Works cross-functionally and with external vendors to proactively manage the...
and observations resulting from QA reviews. QC EDD/AML alerts and cases generated from Verafin. Perform testing to ensure the... required. Prior compliance and/or audit experience highly preferred. Prior financial institution experience as a BSA Investigator...
for FDA audits. Serves as liaison between the investigator, the research team and the FDA during an actual inspection. Records.... 9. Assesses the risk and stratify the study from a QA/regulatory compliance perspective based on clinical research...
programs Assist with the preparation of investigator-initiated trials to include coordination of the protocol submission....gov, including facilitation of Quality Assurance (QA) Participate in the collection of data, supporting both human...
Responsibilities Administrative: Assists principal investigator with protocol development. Assists principal... investigator as appropriate with the Institute’s protocol review process. Assists the principal investigator in developing the...