Eric S. Lea Email & Phone Number

Toronto, Ontario, Ca

Toronto, Ontario, Ca

Morrisville, North Carolina, Us

Raleigh, North Carolina, Us

SENIOR CLINICAL TEAM LEADER (December 2015 -- Present)-Accountable for all clinical monitoring deliverables for all assigned projects, including large, complex global trials-Expanded management responsibilities, including; mentoring and leadership of Clinical Team Leaders and their direct report CRAs (indirect reports)-Liaise with partners for effective trial execution in countries across the globe, including EU, Canada and MexicoCLINICAL TEAM LEADER (December 2013 -- December 2015)-Accountable for all clinical monitoring deliverables for all assigned projects-CRA line management responsibilities, including; interviewing, hiring, training and performance management-Lead and manages entire clinical monitoring project team, including in-house and on-site CRAs-Represent the clinical monitoring team in communications with the sponsor-Liaise, report to and deliver clinical monitoring status to other functional team leaders-Participate in proposal development, preparation and delivery of bid defenses

Fort Washington, Pa, Us

LEAD CLINICAL RESEARCH ASSOCIATE-Provided oversight of all monitoring tasks for 30 US sites on a phase II global asthma trial-Served as the primary liaison between vendors, monitors, and investigative sites-Reviewed and corrected monitoring reports; providing feedback necessary for a timely, and consistently high quality product-Participated in all study leadership teleconferences, including leading weekly calls to provide updates and discuss issues-Facilitated study-specific training for the US monitoring team-Developed and distributed various quantitative and qualitative reports providing weekly updates to US and global study teams-Reviewed Informed Consents and other study-level documents prior to IRB submissionSENIOR SITE MANAGER / SR. CRA-Provided monitoring services for asthma and immunology trials at ~15 sites across the Western US and Canada-Monitored clinical sites to verify data integrity, protocol and regulatory compliance, and drug accountability -Assisted in the identification of and recruitment of qualified investigators-Completed Serious Adverse Event surveillance and reconciliation-Developed study tracking/management spreadsheets and automated study tools-CRF and Informed Consent Form design and review

Alameda, California, Us

-Lay-off due to company-wide reduction in force-Regionally based position that combined the knowledge and skill sets of a Clinical Research Associate, a CRA Manager, and a Strategic Scientific Liaison-Region included the Western United States and CanadaDuties included:-Training, mentoring, and evaluating new CRAs and other clinical personnel-Curriculum writing for CRA training course -Oversight, observation, and evaluation of contract personnel/CROs-Presentation of company pipeline and science to academic audiences-Study monitoring-Developing, building, and maintaining professional relationships with key opinion leaders, physicians, and academic centers in the medical community-Creation of written reports to document visits and CRA evaluations

-Position ended due to company closure-Monitored multiple cardiology trials at 12 sites across the Western US and Canada-Verified data integrity, protocol and regulatory compliance, and drug accountability -Assisted in the identification and recruitment of qualified investigators-Followed-up on Serious Adverse Events-Applied hand-held (PALM OS) solutions to clinical research-Mentored new Clinical Research Associates

Bedminster, Nj, Us

-Monitored 5 phase II/III oncology trials at ~16 sites across the Western US and Canada-Monitored clinical sites for source document verification, protocol and regulatory compliance, and drug accountability -Followed-up on Serious Adverse Events and reconciled events with the clinical data source

Raleigh, North Carolina, Us

-Member of PRA’s Focus Program, designed to mentor new monitors-One of a select group prepared for the particular demands of oncology monitoring-Intensive training and testing with an emphasis on regulations and monitoring skills -International Conference on Harmonization guidelines (ICH)-United States Code of Federal Regulations (CFR)/Good Clinical Practice (GCP)-Monitored two phase II/III oncology trials at 16 clinical sites across five western states-Sought accelerated FDA approval for a new, oral anti-angiogenesis agent

Bs, Physics, Chemistry

General Studies