Career Center

The Clinical Research Specialist II working in the Heart Center Clinical Research Program will coordinate daily operations of the Data Coordinating Center (DCC) for the TEAMMATE Trial, a multicenter randomized clinical trial of immunosuppression therapy in pediatric heart transplant recipients, and a regional philanthropic organization that supports multicenter research studies in congenital heart disease.

This Clinical Research Specialist II will be responsible for:

• Assists Principal Investigators (PIs) and Study Director in planning and implementing clinical research studies.
• Assists in preparing case report forms, form completion guidelines, research manuals, data summary reports, progress reports, and safety reports for clinical research studies.
• Develops, implements, and coordinates clinical research training activities for study personnel.
• Coordinates efforts of local study sites and Core Laboratories with respect to study procedures and operations
• Maintains clinical research study documentation.
• Complies with all institutional policies and government regulations pertaining to human subjects protections.
• Oversees and coordinates daily operation of multiple research studies.
• Develops and implements systems and procedures to meet study goals and protocol requirements.
• May plan, assign, prioritize and supervise work of administrate and support personnel and consultants on contract related activities.
• Acts as a resource to clinical research staff to ensure standards for data management and quality assurance are adhered to.
• Works with site personnel to develop and maintain systems for data collection and preparation of unit budget.
• Prepares monitors and justifies project budgets according to hospital and funding agency specifications.
• Monitor expenses, identifies and resolves errors or discrepancies.
• May maintains financial records and prepare related reports.

• Bachelor's degree, and a minimum of 4 years of relevant work experience or a Master's Degree and 2 years of relevant work experience.