Clinical Trials Proj Mgr II

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):

601 Elmwood Ave, Rochester, New York, United States of America, 14642

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400119 Surgery-Cancer Control

Work Shift:

UR - Day (United States of America)

Range:

UR URG 111

Compensation Range:

$63,815.00 - $95,723.00

The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

Responsibilities:

The Clinical Trials Project Manager II for NCORP is responsible for leading the planning, implementation, and monitoring for multiple, large, national, multi-site clinical research protocols in a network of over 800 community sites. Under oversight of the Manager of Clinical Trials Projects, the Clinical Trials Project Manager will manage multiple studies’ day-to-day operations, carry out project management for clinical trials run through the URCC NCORP network from protocol development and initiation to study close-out according to regulatory/NCI guidelines, and ensure each study’s integrity. S/he will monitor and maximize adherence to research standards, regulatory guidelines, and approved operational procedures; work closely with study team members and other staff/faculty/study sites from all cross functional teams to ensure study participant safety and adherence to study protocol; manage study-related tasks; and facilitate across-the-board flow of information, orchestrating study activities and personnel. The Clinical Trials Project Manager will facilitate excellent customer service and guidance to clinical and study teams in the clinical trials environment. This role is fully on-site with no remote work with standard work hours between 7am and 5pm.

ESSENTIAL FUNCTIONS

Manage all aspects of assigned high volume, multisite clinical research projects including:                                   

• Serve as the primary contact for protocol and data-related questions and issues from off-site locations. The URCC NCORP Research Base has 30+ members, each of which are comprised of many community sites, over 800 in total.
• Ensure off-site investigators and their clinical research staff understand and adhere to all aspects of assigned protocols, procedures, interventions, and standards for documentation and communication
• Train sites research staff on details of study activities, including inclusion and exclusion criteria, informed consent procedures, process for source documentation and case report form (CRF) completion, and adverse event reporting.
• Assist with monitoring the studies regularly for conformity with standard operating procedures and verify data to ensure compliance with requirements of the protocol, Research Base, IRB, University and federal regulations.
• Track study-specific metrics (i.e., overdue data, open queries, etc.) and ensures issues are addressed promptly.
• Learn and maintain working knowledge of software and/or specialized equipment, procedures and interventions used in each project.
• Develop and maintain workflow, records of research activities, and prepare periodic, and ad hoc reports, as required by investigators and/or regulatory bodies.
• Ensure protocol timelines are met (e.g., patient, study, data).
• Ensure proper reporting of adverse events to PI and Research Base Administration.
• Attend and present updates at weekly study management team meetings.

Maintains oversight of high-volume study data for the assigned projects:                                                             

• Work with Clinical Trial Chairs, Co-Chairs, Data Management, IT, Regulatory, Biostatistical, Data Science, and other relevant teams to establish appropriate data handling procedures, methods for collection, databases, coding keys, storage, and tracking of data for assigned projects.
• Oversee receipt and verification of incoming data received from our community sites in multiple formats, i.e., REDCap, scannable paper forms, activity trackers,