Clinical Research Specialist I

University of Rochester • Rochester, NY

1d • 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.

Under supervision, coordinates the enrollment of participants to simple studies. Performs chart review and pre-screening for eligibility and coordinates simple clinical research protocols. Assists in planning study timelines and schedules appointments and study visits. Manages and organizes case report forms, source documents, and research records. Assists in conducting quality checks for data accuracy with data source records as assigned. Maintains study continuity and coordinates study participants and research procedures. Under supervision, ensures protocol compliance and coordinates logistics, research procedures, and study participants. Identifies and documents adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study. Performs data collection and data entry activities according to protocol requirements and established operational procedures and timelines. Observes for deviations and takes action to minimize them. Reports deviations when they occur. Continues to learn how to recognize and report logistical challenges in protocol implementation to the research team, assisting in resolving challenges. Assists in identifying and developing data collection tools. Assists the data coordinator in simple data tasks. Performs quality checks for data accuracy, reports/follows-up with discrepancies. Maintains all logs, including OnCore system entry and research tabs in the Electronic Medical Record (EMR), according to UR and department Standard Operating Procedures (SOPs). Assists in entering research data into data collection forms and/or study databases. 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. 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. Gains knowledge in medical research terminology. Continues to gain 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.

Requirements

• Bachelor's degree required Or equivalent combination of education and experience
• Understands and follows simple research protocols and procedures preferred
• Fully adheres to applicable safety and/or infection control standards preferred
• Understands and follows data integrity standards and processes preferred
• Strong interpersonal, communication, and organizational skills preferred
• Highly collaborative, works well in teams preferred
• Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet preferred

Responsibilities

• Coordinates the activities associated with human subject research.
• Assumes responsibility for the least complex clinical research protocols and timelines.
• Performs structured work assignments.
• Coordinates the enrollment of participants to simple studies.
• Identifies and documents adverse events per protocol.
• Performs data collection and data entry activities.
• Observes for deviations and takes action to minimize them.
• Performs chart review and pre-screening for eligibility and coordinates simple clinical research protocols.
• Assists in planning study timelines and schedules appointments and study visits.
• Manages and organizes case report forms, source documents, and research records.
• Assists in conducting quality checks for data accuracy with data source records as assigned.
• Maintains study continuity and coordinates study participants and research procedures.
• Ensures protocol compliance and coordinates logistics, research procedures, and study participants.
• Advocates for study participants and quality standards throughout the lifespan of the study.
• Reports deviations when they occur.
• Learns to recognize and report logistical challenges in protocol implementation to the research team, assisting in resolving challenges.
• Assists in identifying and developing data collection tools.
• Assists the data coordinator in simple data tasks.
• Performs quality checks for data accuracy, reports/follows-up with discrepancies.
• Maintains all logs, including OnCore system entry and research tabs in the Electronic Medical Record (EMR), according to UR and department Standard Operating Procedures (SOPs).
• Assists in entering research data into data collection forms and/or study databases.
• 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.
• 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.
• Gains knowledge in medical research terminology.
• Continues to gain 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level