Clinical Project Monitor - Clinical Trials Coordination Center

The Clinical Trials Coordination Center (CTCC) conducts worldwide, high quality multi-center clinical research studies, with the goal of developing new treatments and a better understanding of diseases to improve the health or quality of life of patients and families. We are seeking experienced, enthusiastic clinical project monitors to oversee investigator compliance with clinical trial protocols and applicable guidelines. Our ideal candidate is adaptable and at ease in working with multiple research teams. Good communication skills and dedication to follow through is essential, as is a willingness to travel. This position is in person, though with the potential for a hybrid work schedule, and so applicants should be NYS residents or be willing to relocate.

For information on the Center for Health + Technology, download our brochure.

Responsibilities May Include

• Conduct on-site and remote monitoring activities to ensure investigative sites are complying with clinical trial protocols and all applicable GCP and federal guidelines
• Participate in the development and implementation of Quality and Risk Management Plans
• Participate in study start-up process, including the identification and initiation of new sites, development of monitoring plan and clinical trial site staff training
• Perform risk based and centralized data review
• Establish productive working relationships with clinical trial sites
• Serve as a CTCC ambassador to clinical trial sites – to communicate the CTCC’s values, services, and commitment

Requirements

• Bachelor’s degree, with major course works in appropriate health, social science, or biological science field
• 3-5 years of experience in clinical research (or equivalent combination of education and experience).
• Experience in bio/pharma/CRO preferred.
• Extensive knowledge of ICH, GCP Guidelines, and local regulatory authority regulations.
• Experience with electronic data capture systems and familiarity with risk based modeling approach.
• U.S. nationwide travel may be required up to approximately 40%.

Benefits

• Be part of a team conducting unprecedented studies to develop new treatments and measures for diseases including Parkinson’s disease, Huntington disease, and other neurological conditions
• Opportunity to learn new skills and develop expertise in areas such as risk based monitoring, decentralized trials, and monitoring of multi-center global clinical trials
• Collaborate with innovators from academic institutions, biotechnology and pharmaceutical companies, and nonprofit organizations
• Work closely with national leaders in Parkinson and Huntington disease care and research
• Benefits associated with being part of the University of Rochester, including potential tuition benefits and access to other educational opportunities

To Apply

Please send resume and one-page cover letter to Natasha Andrievskaia.

The University of Rochester is an Equal Opportunity Employer.