Clin Research Data Spec I

University of Rochester•Rochester, NY

3d•$22 - $31•Onsite

About The Position

The Clinical Research Data Specialist I assists with creating, updating, and maintaining research charts and case report forms, including regulatory-related materials, in accordance with departmental standard operating procedures. The role coordinates with principal investigators, staff, and sponsor-designated contacts to resolve data inquiries and supports timely, accurate, and compliant data reporting by compiling, registering, and submitting data; monitoring protocol compliance; and following applicable procedures, regulations, and guidelines. The specialist inspects clinical and research data from electronic records and other sources, supports study staff with entering data into electronic systems, and reviews submissions for accuracy and completeness. The role develops source data worksheets and data collection forms, maintains study logs, investigates data collection in electronic data capture systems, and communicates with investigators and cross-functional study teams to improve data review and handling. The specialist maintains knowledge of applicable policies and procedures, completes mandatory training and continuing education, and undertakes other duties as assigned.

Requirements

Bachelor's degree, or an equivalent combination of education and experience.
Accuracy and attention to detail when completing assignments.
Ability to process and handle confidential information with discretion.
Commitment to the University's core values.
Ability to work independently and collaboratively.
Understanding of and adherence to data integrity standards and processes.
Strong interpersonal, communication, and organizational skills.
Ability to work collaboratively in teams.
Proficiency in Microsoft Office, including Word, Excel, and PowerPoint, as well as email and the internet.

Nice To Haves

Ability to understand and follow standard research protocols and procedures.
Knowledge of medical terminology.

Responsibilities

Create, update, and maintain research charts and case report forms, including regulatory-related materials, according to departmental standard operating procedures.
Coordinate with principal investigators, staff, and sponsor-designated contacts to resolve data inquiries.
Compile, register, and submit study data, and monitor compliance with protocols, standard operating procedures, regulations, and guidelines.
Answer simple data clarifications independently and address more complex clarifications with management guidance.
Inspect clinical and research data from electronic records and other sources, and assist study staff with entering data into electronic systems.
Support collection and analysis of research protocols and coordinate with primary and sub-investigators.
Review submitted data for accuracy and completeness and identify actions needed to resolve errors, omissions, or discrepancies.
Ensure study requirements are documented and meet internal and external regulations and protocol guidelines.
Develop source data worksheets for assigned studies to support accurate source documentation.
Prepare and maintain electronic logs and data status updates for routine Principal Investigator Oversight meetings.
Investigate and report data collection in electronic data capture systems promptly and according to protocol guidelines and departmental procedures.
Maintain screening, enrollment, sponsor-specific, and other protocol-required logs.
Work with investigators and cross-functional study personnel to establish appropriate data collection methods.
Design and create data collection forms and communicate with study teams to optimize data review and handling.
Ensure appropriate quality assurance procedures are in place for error detection and correction.
Maintain current knowledge of applicable federal, state, sponsor, and institutional policies, laws, standard operating procedures, and guidelines.
Maintain required skills and complete mandatory safety, equality, responsible conduct of research, continuing education, research competency, and protocol-related training.
Perform other duties as assigned.