Sentences with phrase «ich guidelines»

Solid knowledge of GCP / ICH guidelines and FDA regulations.

• Maintained clinical sites and ensured compliance with Clinipace SOPs, local regulations and ICH guidelines • Developed trip reports and tracked sponsor communications • Assessed clinical trials for growth and development and coordinated efforts between Lead Clinical Research Team, Trial Manager, Monitor manager and trained monitors • Assisted with audits and general queries

• CCRC and SoCRA certification • Data management • Microsoft Office, Outlook • Medical records systems • Electronic clinical trials databases • ICH guidelines

Exercised judgment and use of knowledge of FDA and ICH guidelines and product labeling in performing initial case assessment for seriousness, expectedness, causality, listedness and reporting requirements

Ensured study documentation is completely and properly maintained in accordance with the sponsor protocol, SOPs, GCPs, ICH Guidelines and FDA regulations

Implemented and monitored clinical trials to ensure sponsor and investigator obligations are being met and compliant with applicable local regulatory requirements and ICH guidelines.

Monitored 6 - 8 protocols with varying indications at multiple sites across the country to ensure adherence to the protocol and compliance with ICH guidelines, GCPs and FDA regulations.

Assisted in development and implementation of clinical trials, coordinate assigned clinical trials and ensured compliance with GCP / ICH guidelines.

Performed investigative site file reconciliation, requests any new or updated site - related essential and non-essential documents and reviews them for content, consistency with other documents and compliance with appropriate local regulatory requirements, ICH guidelines, project SOPs and sponsor requirements.

Instructed investigator site staff in their responsibilities and ensures compliance with GCP and ICH guidelines.

Familiar with clinical practices, clinical research ethics, ICH guidelines, FDA CFR, pharma codes, and other applicable local regulations

Recent research focuses on vaccine development in accordance with current ICH guidelines (QbD and PAT) and the development of new platform - technology for vaccines.

Not exact matches

All experimental activities are performed following Standard Operation Procedure (SOP) and validation studies are designed following international guidelines (ICH Q2 (R1).

Prepare Coordinate, review and finalization of various clinical operations / trial - related documents (i.e., Trial master file, protocols / amendments, informed consent forms, Study operations manuals / sheets, advertisements, data management / analysis plans and clinical study reports) according to ICH - GCP guidelines and CFR Part 11 for completeness, accuracy and legibility.

Senior SME for Process Development and Improvement adhering to CFR Part 211, GMPs and ICH Q7A FDA guidelines.

Tags for this Online Resume: Argus 7.0.3, Adverse event reporting, MedDRA conventions, Microsoft Office, ICH - Guidelines, Communication skills, Arisg

Maintains CITI certification and ongoing knowledge of ICH - GCP, federal, state and institutional policies, guidelines and regulations...