Sr. Clinical Research Specialist

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):

265 Crittenden Blvd, 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 110

Compensation Range:

$60,431.00 - $84,603.00

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:

Provides leadership in planning, implementing, monitoring, and evaluating multiple clinical research protocols. Manages the day-to-day operations of multiple studies, carrying out study coordination duties from protocol development and initiation through to study close-out in accordance with regulatory/sponsor guidelines, ensuring the integrity of each study, and mentoring less experienced staff. Monitors and maximizes adherence to research standards, regulatory guidelines, and approved operational procedures. Works closely with study team members and other study sites to ensure the safety and adherence of study participants to the study protocol. Manages study-related administrative and human resources tasks and facilitates across-the-board flow of information, orchestrating study activities and personnel.

ESSENTIAL FUNCTIONS

• Coordinates enrollment of participants. With minimal supervision, coordinates the implementation of multiple complex clinical research protocols. Oversees and facilitates eligibility screening and study recruitment activities. Implements strategies to increase accruals and may perform second eligibility checks as delegated by leadership. Addresses e-mail and phone inquiries, participates in discussions with candidates in the clinic, and consents for non-treatment trials. Plans study timelines and schedules appointments and study visits. Manages and organizes case report forms, source documents, and research records. Enters research data into data collection forms and/or study databases. Assists in conducting quality checks for data accuracy with data source records as assigned. Develops and implements strategies to promote adherence to cultural competency guidelines, meet participants’ needs for language translation, health literacy, etc. Assumes leadership in protocol implementation and study progress, keeping investigators apprised of study progress.
• Manages and coordinates multiple complex studies and study patients. Maintains study continuity and coordinates study participants and research procedures. Identifies and documents adverse events according to protocol, advocating for study participants and upholding quality standards throughout the study's lifespan. Provides leadership in resolving logistical challenges to ensure study objectives are achieved according to protocol and the projected timeline. Performs data collection and data entry activities according to protocol requirements and established operational procedures and timelines. Plans and operationalizes strategies to monitor, document, report, and follow up on unanticipated occurrences and protocol deviations. Develops and implements preventive/corrective actions. Assists in identifying and developing data collection tools. Performs quality checks for data accuracy, reports, and follows up with discrepancies. Assists in safety and quality improvement efforts, minimizing risks and safety threats. Prepares for and responds to internal and external audits. Effectively communicates with the research team, sponsor, data coordinating centers, compliance monitors, collaborators, investigators, academic administrative personnel, and other departments.
• Lead the conduct of systematic reviews; support the preparation and submission of grant applications; and assist with Research Ethics Board (REB) applications, amendments, and continuing reviews, ensuring compliance with institutional and regulatory requirements.
• Assists in training less experienced research personnel in research competencies, UR and department SOPs, and protocol-specific training. Assumes the trainer ro