Robert Scarborough - Regional Manager Resume Simple
A highly motivated, detail-oriented, and results-driven professional with over 10 years of experience in the health care industry. Strong background in the areas of pharmacy and pharmaceutical operations.
Assisted in the development of recruitment strategies and quality plans. Managed the preparation of SOPs, tools, and documents for the study.
Developed monitoring tools for ICH-GCP, FDA, and IRB approved ICFs, CRFs, and other documents.
Performed source documentation verification, case report form completion, and query resolution. Resolved queries in a timely manner.
Completed site visit reports, confirmation and follow-up letters, and study closeout documents as required by the trial Master file (TMF).
Verified that all data entered into the trial Master file (CRFs) are accurate, complete, and in a timely manner.
State of Utah
Attended investigator meetings and training sessions as requested. Ensured that SOPs were followed and that the study was conducted in accordance with the protocol.
Conducted site initiation visits, reviewed and verified all types of monitoring visit reports, and prepared study visit reports for FDA approval and management.
Maintained site files, databases, study manuals, and other documents as required by ICH/GCP guidelines and quality control procedures.
Performed site training, study start up, and trial file audits; assist in the preparation of regulatory documents for submission to the IRB.
Maintain study site training records, including but not limited to, enrollment logs, EDC, and trial Master file.
Coordinated with recruiting and enrollment team to ensure that trial timelines are met and training are met. Responsible for the preparation of study materials, including informed consent, source documents, and case report forms.