Clinical Research Spec II

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.
• 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.
• Affords assistance 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.
• 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.

Qualifications

• Bachelor's degree and 1 year of relevant experience required
• Or equivalent combination of education and experience