Clinical Research Specialist II

University of Rochester•Rochester, NY

7d•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. Responsibilities: Assists in the planning, coordinating, implementing, monitoring, and evaluating specific clinical research studies as assigned. Assists in the day-to-day operations in 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 across-the-board flow of information, and assists in coordinating study activities, and personnel.

Requirements

Bachelor's Degree or equivalent combination of education and experience required
1 year of clinical research or relevant work experience
or equivalent combination of education and experience required
Fluent English language skills (oral and written) required.

Nice To Haves

Ability to understand, follow and coordinate standard research protocols and procedures
Understands and follows data integrity standards and processes.
Strong interpersonal, communication (verbal and written), and organizational skills.

Responsibilities

Participates in recruitment activities, and performs screening and eligibility checks for potential study participants.
Addresses email and phone inquiries, participates in discussions with candidates in clinic, and consents for 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.
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 and documents deviations when they occur.
Identifies and problem solves logistical challenges in protocol implementation with the research team, assisting in resolving challenges.
Effectively communicates with the research team, sponsor, data coordinating centers, compliance monitors, collaborators, investigators' academic administrative personnel, 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).
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.
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.