Clinical Research Data Spec I

University of Rochester • Rochester, NY

2d • $22 - $31 • 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 assists in creating, updating, and maintaining research charts and case report forms, including regulatory related issues, in accordance with department standard operating procedures. The Clinical Research Data Specialist coordinates with the Principal Investigators (PI), staff, and sponsor-designated contacts to resolve data inquiries as needed. This position is 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. The role also answers simple data clarifications (i.e. data queries) for each study.

Requirements

• Associate's degree and 1 year of relevant experience required
• 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

Nice To Haves

• Bachelor's degree preferred
• Or equivalent combination of education and experience
• Ability to understand and follow standard research protocols and procedures preferred
• Knowledge of medical terminology preferred

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.

Benefits

• The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University’s Mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree