University of Rochester Advancement · 2 months ago
Clinical Research Spec II
James P. Wilmot Cancer Center
Full-time
Hybrid
Entry Level
$24.91/hr - $34.87/hr
1+ years expThe University of Rochester is committed to fostering an inclusive community, and they are seeking a Clinical Research Spec II to assist in the planning, coordinating, and implementation of clinical research studies. The role involves managing participant enrollment, ensuring study integrity, and adhering to regulatory guidelines.
Higher Education
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
Qualification
Required
Bachelor's degree and 1 year of relevant experience required
Or equivalent combination of education and experience
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
Preferred
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
Company
University of Rochester Advancement
The University of Rochester, one of the nation’s top private research universities, has built a national caliber advancement program in support of the largest campaign in the University’s history.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase