Clinical Research Data Spec I

The University of Rochester is a community committed to excellence, inclusion, and the principle of Meliora—ever better. The Clinical Research Data Spec I assists with collecting, reviewing, maintaining, and reporting clinical research data while coordinating with investigators, study personnel, and sponsors to ensure protocol, regulatory, and data-quality compliance.

Responsibilities

Assists in creating, updating, and maintaining research charts and case report forms, including regulatory related issues, in accordance with department standard operating procedures. Coordinates with the Principal Investigators (PI), staff, and sponsor-designated contacts to resolve data inquiries as needed. 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. Answers simple data clarifications (i.e. data queries) for each study

Inspects clinical data and research data from electronic records and other sources and assists study staff on entering this data into electronic medium for each assigned study. Supports the collection and analysis of research protocols and coordinates with the primary and sub-investigators. Reviews all data submitted for accuracy and completeness and determines if any actions are required to resolve any errors, omissions or discrepancies. Independently answers simple data clarifications and answers more complex data clarifications under guidance from management. Ensures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines. Develops source data worksheets specific to each assigned study to ensure accurate source documentation

Assists with the preparation and maintenance of electronic logs and data status updates to be presented routinely at PI Oversight meetings. Investigates and reports on data collection into an electronic data capture system in a timely manner according to protocol guidelines and department standard operating procedures (SOPs). Maintains screening, enrollment, and other sponsor and/or protocol specific logs, as required by protocol and department SOPs

Works closely with the investigators and study personnel from all cross-functional teams to establish appropriate data collection methods to meet the needs for each assigned project. Designs and creates data collection forms and communicates regularly with the study team to optimize data review and handling processes. Ensures that appropriate quality assurance procedures are in place for error detection and correction

Maintains currently knowledge and practice of all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines

Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies. Demonstrates accountability for continuous learning and participates in protocol-related training as required

Other duties as assigned

Preferred

Bachelor's degree preferred

Ability to understand and follow standard research protocols and procedures preferred

Knowledge of medical terminology preferred

Research Protocols

Medical Terminology

Company

Private research university offering bachelor's, master's, and doctoral degrees.

Rochester, New York, USA

https://www.rochester.edu/

Founded in 1850

10001+ employees

Qualifications

Associate'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 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 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

Bachelor's degree preferred

Ability to understand and follow standard research protocols and procedures preferred

Knowledge of medical terminology preferred

Required skills

Microsoft Office, Data Integrity Standards, Clinical Research Protocols, Medical Terminology

Preferred skills

Bachelor's degree preferred, Knowledge of medical terminology preferred, Glassdoor, 3.9, Rochester, New York, USA, https://www.rochester.edu/, H1B Sponsorship, Data Powered by, Distribution of Different Job Fields Receiving Sponsorship, 30, Represents job field similar to this job, Engineering and Development, Education and Training, Customer Service and Support, Management and Executive, Human Resources, Accounting and Finance, Creatives and Design, Trends of Total Sponsorships, *2026, (126), 2025, (233), 2024, 2023, (130), 2022, (106), 2021, (100)

Experience

1+ years