Clin Research Data Spec I

University of Rochester•City of 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 position coordinates with the Principal Investigators (PI), staff, and sponsor-designated contacts to resolve data inquiries as needed. The Clin Research Data Spec I 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. They will answer simple data clarifications (i.e. data queries) for each study. Essential functions include inspecting clinical data and research data from electronic records and other sources and assisting study staff on entering this data into electronic medium for each assigned study. The role supports the collection and analysis of research protocols and coordinates with the primary and sub-investigators. It involves reviewing all data submitted for accuracy and completeness and determining if any actions are required to resolve any errors, omissions or discrepancies. The position independently answers simple data clarifications and answers more complex data clarifications under guidance from management. It ensures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines. The role also develops source data worksheets specific to each assigned study to ensure accurate source documentation. Additionally, the Clin Research Data Spec I assists with the preparation and maintenance of electronic logs and data status updates to be presented routinely at PI Oversight meetings. It 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). The role maintains screening, enrollment, and other sponsor and/or protocol specific logs, as required by protocol and department SOPs. The position 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. It designs and creates data collection forms and communicates regularly with the study team to optimize data review and handling processes. The role ensures that appropriate quality assurance procedures are in place for error detection and correction. The Clin Research Data Spec I maintains currently knowledge and practice of all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines. It also maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies. The role demonstrates accountability for continuous learning and participates in protocol-related training as required. Other duties as assigned.

Requirements

Bachelor's degree required
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

Nice To Haves

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.