Sr Clinical Research Data Specialist

University of Rochester

1d•Remote

About The Position

The Sr Clinical Research Data Specialist works in partnership to provide high quality, accurate data management support for complex studies. This role involves coordinating with investigational faculty, clinical trial office staff, and sponsor-designated contacts to resolve data inquiries. The specialist formulates, organizes, and articulates data entry plans, manages assigned caseloads, and supports less experienced staff, acting as a Subject Matter Expert in data management and mentoring team members. Responsibilities include maintaining a working knowledge of parallel processes integrated with clinical trial data, and ensuring the compilation, registration, and submission of data, monitoring compliance with protocols, Standard Operating Procedures (SOPs), and all applicable regulations and guidelines for timely, accurate, and compliant data reporting. Key functions also include conducting quality checks, performing data entry and verification, providing custom programming, statistical analysis, reporting, and presentation graphics, and preparing and transferring data for analysis. The specialist supports the implementation of custom, research project-specific data workflow solutions and adheres to defined application development life-cycle practices. The role consults with user departments and sites to assess data preparation and management needs, offers solutions for efficiency, and partners to provide data status reports. The specialist answers data clarifications, fields complex inquiries, schedules and meets with study monitors, assists in audit preparation, develops source data worksheets, and ensures clinical issues are addressed. They also prepare various reports, observe and report deviations, maintain requisite skills and certifications (CITI and COI), gain knowledge in medical research terminology and UR-specific research software, participate in training, and collaborate on training modules. Adherence to all federal, state, sponsor, and institutional policies and procedures is required.

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

Nice To Haves

CCRC - Certified Clinical Research Coordinator preferred
CCRP - Certified Clinical Research Professional preferred

Responsibilities

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.
Other duties as assigned