Clinical Research Spec II

University of Rochester • Rochester, NY

20h • 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.

This role assists in the planning, coordinating, implementing, monitoring, and evaluating specific clinical research studies as assigned. It involves day-to-day operations, protocol implementation, and ensuring the integrity of studies according to regulatory and sponsor guidelines. The position requires close collaboration with study team members and other sites to ensure participant safety and protocol adherence, while also managing administrative tasks and information flow.

Requirements

• Bachelor's degree and 1 year of relevant experience required Or equivalent combination of education and experience
• Ability to understand, follow and coordinate standard research protocols and procedures required
• Fully adheres to applicable safety and/or infection control standards required
• Understands and follows data integrity standards and processes required

Nice To Haves

• Strong interpersonal, communication, and organizational skills preferred
• Highly collaborative, ability to work well in teams preferred
• Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet preferred

Responsibilities

• Assists in the planning, coordinating, implementing, monitoring, and evaluating specific clinical research studies as assigned.
• Assists in day-to-day operations and the implementation of clinical research protocols.
• Assists in carrying out study coordination duties from protocol initiation to study close-out according to regulatory/sponsor guidelines.
• Assists in assuring the overall integrity of studies.
• Assists in monitoring and adhering to 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 approved protocols.
• Helps with study-related administrative tasks, facilitates the across-the-board flow of information, and assists in coordinating study activities and personnel.
• Coordinates enrollment of participants.
• Manages and coordinates the enrollment of participants in moderate risk/moderately complex studies.
• Participates in recruitment activities and performs screening and eligibility checks for potential study participants.
• Addresses e-mail and phone inquiries, participates in discussions with candidates in clinic, and consents to non-treatment trials.
• Assists in planning 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.
• Manages and coordinates studies that are of a moderate size and complexity.
• 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.
• Performs data collection and entry activities according to protocol requirements and established operational procedures and timelines.
• Observes for deviations and takes action to minimize them.
• Reports and documents deviations when they occur.
• Identifies logistical challenges in protocol implementation with the research team, assisting in resolving challenges.
• 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.
• Adheres to cultural competency guidelines.
• Implements strategies to meet study participants’ needs for language translation, health literacy, etc.
• Maintains all logs, including OnCore entry and research tabs in the EMR, according to UR and department Standard Operating Procedures (SOPs).
• Assists in identifying and developing data collection tools.
• Assists the data coordinator in data tasks.
• 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.
• 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 the same.
• Participates in protocol-related training as required.
• 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.
• Other duties as assigned.

Benefits

• The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University’s Mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees