Lynn Lyons Email & Phone Number

Responsible for coordinating in-house management of documentation generated by study sites, study monitors and other related sources involved with Sanofi-Aventis clinical research studies in the US. Support projeect team to assure successful completion of a trial in accordance with current federal regulations (ICH/GCP) and SOPs.

• Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites for GCP compliance according to Covance’s SOPs and/or client guidelines.• Resolve queries of CRF data with study site personnel.• Review Tables and Listings generated from study data.• Undertake feasibility work when requested.• Recruitment of potential investigators• Review and reconciliation of Serious Adverse Event (SAE) reported by site• Independently perform CRF review; query generation and resolution per CRF completion guidelines.• Perform training, mentoring, and development of new employees, e.g. co-monitoring as requested by project management team.• Acted as a liaison to sponsor company• Therapeutic areas: CNS, Cardiovascular and GI