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ESSENTIAL FUNCTIONS

• Oversees assigned study personnel, including orientation, training, documentation of core competencies, certification mandates, safety/responsible conduct of research education, and performance evaluations. Manages the day-to-day operations, issue resolution, and supervision of assigned staff. Assigns staff to protocols prior to PRMC submission. Completes annual performance evaluations. Performs QA and supervision of team OnCore entries, research tabs, and reports. Reviews applications, interviews, and hires staff as needed. Addresses discipline issues. Oversees and facilitates eligibility screening and study recruitment activities. Implements strategies to increase accrual and performs second eligibility checks. Develops and implements strategies to promote adherence to cultural competency guidelines, meets participants’ needs for language translation, health literacy, etc. Assumes the trainer role for proficiency in use of UR-specific research software needed for their clinical research studies.
• Manages the studies and pipeline portfolio of assigned DWG. Completes operational assessment of proposed new research protocols. Communicates with research team, sponsor, data coordinating centers, compliance monitors, collaborators, investigators, academic administrative personnel, and other departments. Serves as point of contact for DWG physicians. Provides coverage and back-up for team members as needed. Provides leadership in resolving logistical challenges to ensure study objectives are achieved according to protocol and projected time-lines. Assumes leadership in protocol implementation and study progress, keeping investigators appraised of study progress. Performs safety and quality improvement efforts, minimizing risk/safety threats. Prepares for and responds to internal and external audits. Plans and operationalizes strategies to monitor, document, report, and follow-up on unanticipated occurrences and protocol deviations. Develops and implements preventive/corrective actions.
• Obtains and/or maintains clinical research certification. Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines. Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies. Maintains CITI and Conflict of Interest (COI) certification and renewal as required. Maintains proficiency in UR-specific research software needed to manage clinical research protocols. Assumes personal responsibility for keeping up with new developments in the field, related literature, and relevant clinical standards. Assists in helping others in same. Participates in protocol-related training as required.
• Participates in department specific goals. Identifies and develops new department specific SOPs. Updates and revises current SOPs as needed. Participates in staff recruitment and retention initiatives. Participates in department wide team building and training activities.
• Complies with Good Clinical Practice and the Code of Federal Regulations. Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures (SOPs), and guidelines. Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies.
• Other duties as assigned.

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree and 4 years of relevant experience required
• Master's degree preferred
• Or equivalent combination of education and experience
• Previous leadership experience preferred

KNOWLEDGE, SKILLS AND ABILITIES

• Demonstrated leadership skills and competency preferred
• Ability to effectively manage complex research protocols/procedures preferred
• Proficiency in medical terminology, the clinical research process and applicable regulatory guidelines and standards preferred
• Proficiency in managing multiple and competing priorities/demands preferred
• Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, applicable safety standards, OSHA guidelines, throughout study implementation preferred
• Fully adheres to applicable safety and/or infection control standards preferred
• Exceptional interpersonal, organizational, and time management skills; highly collaborative, promotes teamwork preferred
• Ability to build collaboration among research team members, laboratory staff, patients and families, clinical services (requires tact, sensitivity, clarity, flexibility, empathy for patients) preferred
• Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet preferred
• Possesses a high degree of self-motivation preferred
• Recognized ability to function independently preferred

LICENSES AND CERTIFICATIONS

• CCRP - Certified Clinical Research Professional within 1 year required
• SOCRA - Certification In Clinical Research within 1 year required

The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University’s Mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.