Sr Clinical Research Data Specialist Job at University of Rochester (Rochester)

Job Description

Works in partnership with the primary point of contact to provide high quality, accurate data management support for complex studies. Coordinates with the investigational faculty, clinical trial office staff, and sponsor-designated contacts to resolve data inquiries as needed. Formulates, organizes, and articulates data entry plans to manage assigned caseloads and support less experienced staff. Acts as a Subject Matter Expert in data management. Mentors and provides guidance to others on the team. Maintains a working knowledge of parallel processes that are integrated with the function of clinical trial data and 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.

Job Responsibility

Assists in conducting quality checks of data accuracy with data source records as assigned
Perform data entry and verification tasks
Provides custom programming, statistical analysis, reporting and presentation graphics
Prepare and transfer data for analysis
Supports the implementation of custom, research project-specific data workflow solutions for data collection, management, reporting and analytics
Adheres to defined application development life-cycle practices
Consults with user departments and sites to assess data preparation and management needs, program design and testing
package selection and use of systems, software and equipment
Partners with the primary point of contact to provide data status reports and ensures protocol data objectives are scheduled appropriately
Answers a broad range of data clarifications for each study
Fields complex inquiries from investigational, site, and study staff pertaining to study data
Schedules and meets with study monitors and ensures patient cases are ready for each monitor visit and items are addressed after each monitoring visit
Assists in audit preparation
Develops source data worksheets specific to each assigned study
Ensures clinical issues from monitoring reports are addressed and closed out before the next monitoring visit
Ensures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines
Prepares data status update reports to be presented routinely at PI Oversight meetings
Extracts and prepares drug safety profile information for annual reports
Prepares relevant information for DSMC reports as required and requested
Observes for deviations and acts to minimize them
Reports deviations when they occur, addressing adverse events with supervision
Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies
Maintains CITI and Conflict of Interest (COI) certification and renewal as required
Gains knowledge in medical research terminology
Continues to gain proficiency in UR-specific research software needed to manage clinical research protocols
Participates in protocol-related training as required
Acts as a mentor to lower level staff
Provides general support and education to staff
Collaborates with leadership to develop and update training modules and educational opportunities specific to the data coordination team
Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines
Adheres to all UR, Wilmot, and department policies and procedures

Requirements

Bachelor’s degree Required
2 years of relevant experience Required
or equivalent combination of education and experience Required
Skill in completing assignments accurately and with attention to detail Required
Ability to understand and follow standard research protocols and procedures Required
Ability to process and handle confidential information with discretion Required
Possesses a working knowledge of key processes that encompass clinical trials (e.g., Regulatory and Finance), and how these processes are impacted by clinical trial data 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 as outlined in the Code of Federal Regulations (CFR), Good Clinical Practices (GCP), and Good Documentation Practices (GDP) Required
Strong interpersonal, communication, and organizational skills
Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet Required

Nice to have

CCRC - Certified Clinical Research Coordinator Preferred
or CCRP - Certified Clinical Research Professional Preferred

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Sr Clinical Research Data Specialist

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