Clin Research Data Spec II

Job Location: 601 Elmwood Ave, Rochester, New York, United States of America, 14642

Full-time, Regular position with 40 scheduled weekly hours during the day shift.

Compensation Range: $23.27 - $32.60 per hour. Individual salaries will be determined based on factors including market data, education, experience, qualifications, expertise, and internal equity considerations.

Responsibilities

• Assumes responsibility for the data management of clinical research protocols.
• Coordinates with investigational faculty, clinical trial office staff, and sponsor-designated contacts to resolve data inquiries as needed.
• Formulates and organizes data entry plans to manage assigned caseloads.
• Compiles, registers, and submits data, ensuring compliance with the protocol, Standard Operating Procedures (SOPs), and all applicable regulations and guidelines for timely, accurate, and compliant data reporting.
• Conducts quality checks for data accuracy with data source records as assigned.
• Reviews medical records for prospective clinical trial patients in conjunction with study eligibility parameters to assist with enrollment.
• Partners with the primary point contact to provide data status reports and ensure protocol data objectives are scheduled appropriately.
• Manages a workload of studies commensurate with level of experience and answers data clarifications for each study.
• Schedules and meets with study monitors, ensuring patient cases are ready for each monitor visit and items are addressed afterward.
• Develops source data worksheets specific to each assigned study.
• Ensures clinical issues from monitoring reports are addressed and closed out before the next monitoring visit.
• Ensures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines.
• Prepares data status update reports for routine presentation at PI Oversight meetings.
• Extracts and prepares drug safety profile information for annual reports.
• Prepares relevant information for DSMC reports as required and requested.
• Observes for deviations and acts to minimize them; reports deviations when they occur, addressing adverse events with supervision.
• Maintains study binders and filings according to protocol requirements and department policy.
• Prepares source documentation logs for review by trial investigators by extracting this information from available source documents.
• Updates data and safety-related information in OnCore and collaborates with trial investigators for review and submission to applicable sponsors and regulatory authorities.
• Maintains screening, enrollment, and other sponsor and/or protocol-specific logs.
• Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines.
• Adheres to all UR, Wilmot, and department policies and procedures.
• 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 and continues to gain proficiency in UR-specific research software needed to manage clinical research protocols.
• Participates in protocol-related training as required.
• Performs other duties as assigned.

Requirements

• Bachelor's degree and 1 year of relevant experience required, or equivalent combination of education and experience.
• Skill in completing assignments accurately and with attention to detail.
• Ability to understand and follow standard research protocols and procedures.
• Ability to process and handle confidential information with discretion.
• Commitment to the University’s core values: equity, leadership, integrity, openness, respect, and accountability.
• Ability to work independently and/or in a collaborative environment.
• Understands and follows data integrity standards and processes as outlined in the Code of Federal Regulations (CFR), Good Clinical Practices (GCP), and Good Documentation Practices (GDP).
• Strong interpersonal, communication, and organizational skills.
• Highly collaborative, works well in teams.
• Proficient in MS Office (e.g., Word, Excel, and PowerPoint), email, and internet.