Manager, Clinical Research

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.

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ESSENTIAL FUNCTIONS

• Participant recruitment, enrollment, and retention: Oversees, coordinates and conducts human subject research activities for single or multiple sites. Recruits and enrolls participants. Follows up with study participants regarding assessments and document communications, including protocol deviations
• Supervisory duties: Trains new research staff members and/or student employees on the activities associated with conducting human subject research specific to study protocols and in compliance with Good Clinical Practice (GCPs) guidelines and sponsor requirements. Directs the activities of staff members to gather, compile and analyze study information. Manages study-related administrative and human resources tasks and facilitates across-the-board flow of information, orchestrating study activities, and personnel. Provides feedback to staff members for annual reviews and ensures all staff specific plans for improvement are implemented appropriately (as needed).
• Data Management:  Develops, implements and monitors systems and methods to ensure quality, safety, efficiency and consistency in the processing of human subject research data. Reviews study progress, including data, documentation, and reporting deliverables. Designs, develops, implements, monitors and manages systems and procedures for the purpose of tracking study progression. Monitors and maximizes adherence to research standards, regulatory guidelines, and approved operational procedures and protocols. Ensures all staff members are collecting data from participating families appropriately using standard operating procedures. Ability to create summary data as needed for reporting to the funding agencies, will complete all data exports for funding agencies and ensure documentation is updated appropriately, and edits databases as needed to meet all necessary regulatory guidelines.
• Regulatory: Demonstrates accountability for continuous learning in accordance with Good Clinical Practice guidelines. Keeps current with industry standards, best practices, and relevant to research studies and designs, implements and monitors resulting study changes. Performs study coordination duties from protocol development and initiation to study close-out according to regulatory/sponsor guidelines and ensures each study's integrity. Will maintain all internal and external IRBs for all studies, will complete continuing reviews for all IRB approved studies, will assist with URMC quality improvement audits and will be responsible for submitting all regulatory/sponsor reporting.

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree required
• 4 years of experience required
• Or equivalent combination of education and experience required
• Experience as Human Subject Research Coordinator 1 preferred
• Fully adheres to applicable safety and/or infection control standards required
• Ability to effectively manage complex research protocols/procedures required
• Proficiency in managing multiple and competing priorities/demands required
• Research enrollment of participants and tracking of research participants (retention activities) preferred
• Exceptional interpersonal, organizational, and time management skills required
• Highly collaborative, promotes teamwork, managerial skills required
• Ability to build collaboration among research team members, laboratory staff, research participants and families, clinical services (requires tact, sensitivity, clarity, flexibility, empathy for patients) required
• Possesses a high degree of self-motivation and decision-making skills required
• Proficient in MS Office (e.g. Word, Excel, Teams, and PowerPoint), email, internet, Zoom required
• Recognized ability to function independently, write and edit standard operating procedures (SOPs) for research studies, and liaison for Dr. Sheftall on both local and national levels required
• Ability to assess current job protocols/functions and suggest clear options for efficiency required
• Grant and manuscript writing/editing preferred
• Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, IRB experience (modifications, continuing reviews, etc.), applicable safety standards, OSHA guidelines, throughout study implementation preferred
• Experience with mental health research preferred
• Proficiency in medical terminology, the clinical research process and applicable regulatory guidelines, standards preferred

LICENSES AND CERTIFICATIONS

• CCRP – Certified Clinical Research Professional AND
• SOCRA – Certification in Clinical Research Required within 1 year of hire.

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