Manager, Clinical Research

Job Location: 90 Crittenden Blvd, Rochester, New York, United States, 14642

Full-time, 40 scheduled weekly hours

Compensation Range: $70,600.00 - $105,800.00

Responsibilities

• 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 and 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 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 timelines.
• 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.

Requirements

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

Skills

• 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.