To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #02215

About our client Our client is a specialty pharmaceutical company focused on providing innovative medical therapies for targeted disease classes in high potential markets. Founded in the mid '90s the company has introduced its first product in the market this year. Position Location Lead Clinical Research Associate Pennsylvania Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee the initiation and management of assigned Phase I, II, III, and IV clinical trials 2) Monitor progress within project alignment and assist in recruiting clinical sites 3) Assist in the review of clinical and/or laboratory data to ensure thoroughness and regulatory compliance of clinical documentation 4) Participate in pre-study and site initiation planning 5) Assist in writing FDA submissions (protocol amendments/investigator changes) 6) Liaise with contracted research organizations, field sites, investigators, study coordinators, pharmacists, and staff members 7) Assist in providing technical assistance to study sites regarding the conduct of clinical research 8) Ensure resolution of data queries 9) Assist in liaison activities with Professional Affairs and Regulatory Affairs 10) Perform clinical monitoring, site evaluation, and close-outs 11) Maintain and track clinical studies budget 12) Assure delivery and shipment of drugs and study-related materials 13) Track data forms, reports, and documents necessary for completion of clinical study, from in-house as well as participating study sites 14) Assist in manufacturing, drug development, research, quality assurance and compliance, and accounts payable to facilitate the dissemination of information Requirements 1) Bachelor's degree mandatory 2) 3-5 years' experience in a clinical research environment 3) Ability to travel - weekly (for monitor of clinical studies) 4) Excellent presentation skills