Clin Research Data Spec II

University of Rochester • City of Rochester, NY

2d • $23 - $33 • 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 assumes responsibility for the data management of clinical research protocols. The position coordinates with investigational faculty, clinical trial office staff, and sponsor-designated contacts to resolve data inquiries. It involves formulating and organizing data entry plans to manage assigned caseloads, and is responsible for the compilation, registration, and submission of data. The role monitors compliance with the protocol, adherence to Standard Operating Procedures (SOPs), and all applicable regulations and guidelines to ensure timely, accurate, and compliant data reporting.

Requirements

• Bachelor's degree and 1 year of relevant experience required
• Equivalent combination of education and experience
• Skill in completing assignments accurately and with attention to detail required
• Ability to understand and follow standard research protocols and procedures required
• Ability to process and handle confidential information with discretion required
• Commitment to the University’s core values required
• Ability to work independently and/or in a collaborative environment required
• 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) required
• Strong interpersonal, communication, and organizational skills required
• Highly collaborative, works well in teams required
• Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet required

Responsibilities

• Assumes responsibility for the data management of clinical research protocols.
• Coordinates with the 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.
• Responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, adherence to Standard Operating Procedures (SOPs), and all applicable regulations and guidelines to ensure timely, accurate and compliant data reporting.
• Assists in conducting 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 of contact to provide data status reports and ensure protocol data objectives are scheduled appropriately.
• Manages a workload of studies commensurate to level of experience.
• Answers data clarifications for each study.
• Schedules and meets with study monitors and ensures patient cases are ready for each monitor visit and items are addressed after each monitoring visit.
• 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 to be presented routinely 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 the trial investigators for review and submission to the applicable sponsor(s) 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.
• Continues to gain proficiency in UR-specific research software needed to manage clinical research protocols.
• Participates in protocol-related training as required.
• Other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level