Senior Clinical Research Specialist

Senior Clinical Research Specialist

University of Rochester

Location:

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

• Full time
• Worker subtype:
  Regular
• Scheduled weekly hours: 40
• Department: 400072 Pediatric Hospital Medicine
• Work shift:
  
  UR - Day (United States of America)
• Range: UR URG 110
• Compensation range: $60,431.00 - $84,603.00

Provides leadership in planning, implementing, monitoring, and evaluating multiple clinical research protocols. Manages multiple studies' day-to-day operations, carries out study coordination duties from protocol development and initiation to study close-out according to regulatory/sponsor guidelines, ensures each study's integrity, and mentors 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 study participant safety and adherence to study protocol.

Manages study‑related administrative and human resources tasks and facilitates across‑the‑board flow of information, orchestrating study activities, and personnel.

• 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 accrual and may perform second eligibility checks as delegated by leadership.
• Addresses e‑mail and phone inquiries, participates in discussions with candidates in 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 per protocol, advocating for study participants and quality standards throughout the lifespan of the study.
• Provides leadership in resolving logistical challenges to ensure study objectives are achieved according to protocol and 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, 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 risk/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.
• Maintains all logs, including OnCore entry and research tabs in the EMR, according to UR and department SOPs.
• Assists in training less experienced research personnel in research competencies, UR and department SOPs, and protocol specific training.
• Assumes the trainer role for proficiency in use of UR‑specific research software needed for their clinical research studies.
• 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…