Job Description

Nan Wang, BS, MS Quintiles Enterprise Management (Shanghai) Co., Ltd

July 2011-Apr 2014

Clinical Research Associate

Job Description: Responsible for site selection, initiation, monitoring and close-out, ensuring that studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

Directly accountable to: Bosco Han, Clinical Operation Department, Quintiles, Shanghai, China

Responsibilities include: • Participating in the site eligibility survey and site selection process so as to assure adequate qualifications, training and resources for the investigative sites

• Conducting study start-up activities and performing site initiation

• Performing monitoring according to protocol, GCP and standard operating procedures • Creating monitoring reports and follow-up letters within submission timeline

• communicating and working closely with project leaders, investigators, peer monitors, data management staff, central lab staff and independent end-point committee

• Training investigative site personnel on study protocols and GCP requirements • Escalating compliance and study issues to project leaders

• Conducting monitoring visits to assess protocol adherence, conduct source document verification, verify drug accountability and storage requirements, review the maintenance of study files and ensure compliance with regulatory requirements and AE reporting requirements

• Tracking regulatory submissions and approvals, recruitment and enrollment, CRF completion and data clean

• Performing site close-out, retrieve essential documents for trial master file maintenance, and ensure proper study documents retention at site. •Lead CRA mentoring and supervising other monitor(s).

Travel: 20% at study initiation; about 60% according to project requirement during study;

total employment is about 2100 hours per year. Skills and Experiences:

• Clinical Research Education, Clinical Trial Design and Management Certificate, 2014-present • Master's degree in Biochemistry and Molecular Biology, 2008-2011

• Monitoring experience in global trials: 34 months • Substantial experience using computerized information systems: Outlook, Word, Excel, PowerPoint, CTMS, EDC systems including InForm and RAVE

• Substantial experience with central lab and independent end-point committee • Through knowledge of ICH-GCP and awareness of local regulatory regulations regarding clinical trials

Awards and Honors:

Quintiles' Distinguished Employee in Year 2013

Special Achievement Award for a significant contribution to achieving database lock, 2013 Quintiles' Star CRA Award in Year 2012