Senior Clinical Research Data Specialist

Role Overview

• 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.
• 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, including but not limited to, requirements gathering, writing test plans, data collection system build, peer code review and quality assurance through unit/system/user acceptance testing.
• 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.
• Offers solutions and suggestions to provide optimum efficiency and cost effectiveness.
• 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, ranging from simple to complex.
• Fields complex inquiries from investigational, site, and study staff pertaining to study data, in conjunction with leadership when appropriate.
• 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
• 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 required
• Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet required
• CCRC
• Certified Clinical Research Coordinator preferred or CCRP
• Certified Clinical Research Professional preferred.

Tech Stack

• Google Cloud Platform