Manager, Clinical Research Data

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.

Job Location (Full Address):

275 Hutchison Rd, Rochester, New York, United States of America, 14627

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400178 Cancer Center/Clin Trials Ofc

Work Shift:

UR - Day (United States of America)

Range:

UR URG 111

Compensation Range:

$63,815.00 - $95,723.00

Responsibilities:

Responsible for the day to day training, oversight and management of Clinical Trials Office (CTO) staff and data management function. Manages data reporting. Oversees and delegates staff assignments and manage all CTO data to ensure compliance with Standard Operating Procedures (SOPs) and Good Clinical Practices.

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. Reviews applications, interviews, and hires staff as needed. Addresses discipline issues. Completes annual performance evaluations. Performs Quality Assurance (QA) and supervision of team OnCore system entries, research tabs, and reports. Oversees and facilitates data flow and data entry. Trains staff to ensure proficiency in use of UR-specific research software needed for data coordination and integrity of clinical research studies.
• Manages the data coordination and distribution of resources for assigned staff. Communicates with research team, sponsor, data coordinating centers, compliance monitors, collaborators, investigators, academic administrative personnel, and other departments. Serves as point of contact for Disease Working Group (DWG) physicians regarding data entry and integrity. Provides coverage and back-up for data coordinators 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 data timelines, keeping investigators appraised of study progress. Performs safety and quality improvement efforts, minimizing risk/safety threats. Plans and operationalizes strategies to monitor, document, report, and follow-up on unanticipated occurrences, and protocol deviations. Develops and implements preventive/corrective actions.
• Participates in creating and tracking 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, and guidelines. Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies.
• 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.
• Other duties as assigned.

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree and 3 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 required
• Ability to effectively manage complex research protocols/procedures required
• Proficiency in medical terminology, the clinical research process and applicable regulatory guidelines and standards required
• Proficiency in managing multiple and competing priorities/demands required
• Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, applicable safety standards, OSHA guidelines, throughout study implementation required
• Fully adheres to applicable safety and/or infection control standards required
• Exceptional interpersonal, organizational, and time management skills; highly collaborative, promotes teamwork required
• Ability to build collaboration among research team members, laboratory staff, patients and families, clinical services (requires tact, sensitivity, clarity, flexibility, empathy for patients) required
• Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet required
• Possesses a high degree of self-motivation required
• Recognized ability to function independently required

LICENSES AND CERTIFICATIONS

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

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