Management and monitoring of CRO and investigative sites.
•Participation in Inspection Readiness and Mock inspections.
•QC of CRO's TMF and other clinical trial records
•Management of patient recruitment, non-compliance, safety, document management, investigational product, IP accountability.
•Support global and regional clinical trial managers and trial leaders in the planning, designing, executing, monitoring and reporting of clinical trials.
•Support the global and regional clinical trial managers and trial leaders in the planning, execution and reporting of clinical trials, ensuring alignment of activities with study timelines, budgets, SOPs, GCP and applicable regulatory guidelines.
•Performs an array of assigned duties including investigative site recruitment/feasibility; essential document collection and review; ICF review; study document/plan development and review; maintenance and close-out of in-house site management activities in accordance with the protocol; standard

Maintains timely and effective communication among team members and site staff.
•Routinely anticipates/identifies potential issues and implements corrective actions independently. Keeps project leadership apprised of team issues, seeking guidance as needed. Demonstrates effective conflict resolution.
•Assures compliance with local regulations, Code of Federal Regulations (CFR)/International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor SOPs.
•Maintains current regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan. Participates in TMF and on-site audits as requested. Responds to findings without oversight. May be responsible for submission of regulatory packages to ethics committees and/or competent authorities.
•Responsible for site management and site staff performance including: monitors all types of clinical trials; participates in all types of site visits; assures compliance with all prot

Conducted business in accordance with company's SOPs, FDA regulations, and ICH /GCP guidelines.
•Conducted site qualification visits, site initiation visits, interim monitoring visits, close out visits, and for cause visits for clinical trials
•Served as a resource and assist in the site selection process.
•Executed timely and accurate completion of all monitoring visit reports, and ensure effective follow up and resolution of site issues
•Provided clinical research and study specific training to Investigators and site staff, including implementation of training tools for clinical sites
•Ensured appropriate conduct of clinical studies in accordance with the protocol, manual of procedures, SOPs, GCP, ICH, FDA, NIH, and other regulatory guidelines as applicable
•Worked closely with study sites to offer support and education as needed throughout the study
•Regularly monitored site performance, including enrollment activity, data entry activity, and action item resolution
•Effecti

Overall conduct of one or more clinical trials.
•Recruiting, evaluating and scheduling patients for studies.
•Completed all required study related documents including: obtaining informed consent, Case Report Forms, Source documents, Data management queries, and AE/SAE reporting.
•Gathered missing or incomplete data.
•Collected and organized patient data.
•Tracked investigational product distribution and site inventory.
•Coordinated lab activities.
•Collected urine samples for testing.
•Maintained study manuals, regulatory binders and other materials.
•Assisted in IRB submission and approval process.
•Prepared site for monitoring visits.
•Acted as sponsor liaison to resolve any site related issues quickly and effectively.