University of Rochester Advancement · 3 months ago
Clinical Research Data Specialist
10 Miracle Mile Drive
Full-time
Onsite
Entry Level
$21.36/hr - $29.90/hr
1+ years expThe University of Rochester is committed to fostering an inclusive community and is seeking a Clinical Research Data Specialist. The role involves assisting in the creation and maintenance of research charts, ensuring compliance with protocols, and coordinating data inquiries with investigators and study staff.
Higher Education
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
Qualification
Required
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
Preferred
Bachelor's degree preferred
Ability to understand and follow standard research protocols and procedures preferred
Knowledge of medical terminology preferred
Company
University of Rochester Advancement
The University of Rochester, one of the nation’s top private research universities, has built a national caliber advancement program in support of the largest campaign in the University’s history.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase