Manager, Clinical Research

University of Rochester•Rochester, NY

2d•$70,600 - $105,800•Onsite

About The Position

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. This position is responsible for the day-to-day oversight and management of the assigned Clinical Trials Office and its staff. The role involves managing daily operations, monitoring research activity for compliance with Standard Operating Procedures and Good Clinical Practices, and ensuring study objectives are met according to protocol and timelines. The Manager will also be responsible for staff supervision, training, performance evaluations, and recruitment, as well as operational assessment of new research protocols and communication with various stakeholders including sponsors, data coordinating centers, and investigators. The role requires obtaining and maintaining clinical research certifications and staying current with relevant regulations, industry standards, and best practices.

Requirements

Bachelor's degree and 4 years of relevant experience required
CCRP - Certified Clinical Research Professional within 1 year required
SOCRA - Certification In Clinical Research within 1 year required

Nice To Haves

Master's degree preferred
Equivalent combination of education and experience
Previous leadership experience preferred
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

Responsibilities

Responsible for the day to day oversight and management of the assigned Clinical Trials Office and the assigned staff.
Manages the daily operations within the Clinical Trials Office and monitors research activity to ensure compliance with Standard Operating Procedures and Good Clinical Practices.
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.