University of Rochester · 9 hours ago
Clin Research Data Spec II
Rochester, New York Metropolitan Area
Full-time
Onsite
Entry Level
$23.06/hr - $32.29/hr
1+ years expThe University of Rochester is committed to excellence and inclusion, and they are seeking a Clin Research Data Spec II to manage data for clinical research protocols. This role involves coordinating with faculty and staff, ensuring compliance with protocols, and conducting quality checks for data accuracy.
Health CareMedicalUniversities
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
Qualification
Required
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 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
Company
University of Rochester
The University of Rochester is a private research university located in Rochester, New York.
10001+ employees
H1B Sponsorship
University of Rochester has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (234)
2024 (126)
2023 (130)
2022 (106)
2021 (100)
2020 (92)
Funding
Current Stage
Late StageTotal Funding
$20.43MKey Investors
National Science FoundationUnitedHealthcareSociety to Improve Diagnosis in Medicine
2023-09-25Grant· $18M
2023-07-26Grant· $0.07M
2022-09-20Grant· $0.05M
Leadership Team
David Linehan
Chief Executive Officer
Recent News
2025-12-04
Company data provided by crunchbase