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Job #03043

About our client Our client is a privately held global CRO serving the pharmaceutical and medical device industry. It is built upon a strong foundation of clinical, process and systems expertise. The company provides strong growth opportunities for its employees. Position Location Clinical Research Associate Pennsylvania Salary Highly competitive package, commensurate with experience Responsibilities 1) Monitor clinical trials’ progress (site management/monitoring perspective) while ensuring SOP, protocol, ICH and GCP compliance 2) Coordinate efforts from study start-up through closeout, including collection and reviewing of regulatory documents 3) Provide review of monitoring trip reports 4) Ensure timely and complete reporting of study conduct 5) Identify and document critical issues 6) Develop and maintain SOPs for monitoring functional area 7) Ensure consistent implementation and successful completion of clinical research activities for studies 8) Assist with budget and contract reviews 9) Maintain and track budgets for ongoing clinical studies 10) Provide initial review of monitor expense reports, ensuring accurate and complete reporting of all expenses 11) Identify innovative solutions to accomplish objectives while maximizing resource and budget utilization within the organization 12) Ensure that the monitoring staff is fully trained Requirements 1) BS/BA in a health-related field 2) ACRP-CRA certification a plus 3) 3 – 4 years of experience in a clinical research role (pharmaceutical industry) 4) Minimum 2 years of in-house CRA experience 5) In-depth knowledge of ICH/GCP guidelines 6) Ability to lead and monitor a team based at the company’s overseas office in India 7) Proficiency in computers (MS Word, MS Excel and MS Project) 8) Excellent communication skills (written and verbal) 9) Willingness to travel