Sr Clinical Research Data Spec

University of Rochester•City of Rochester, NY

1d•$25 - $35•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 works in partnership with the primary point of contact to provide high quality, accurate data management support for complex studies. It coordinates with the investigational faculty, clinical trial office staff, and sponsor-designated contacts to resolve data inquiries as needed. The position formulates, organizes, and articulates data entry plans to manage assigned caseloads and support less experienced staff. The Sr Clinical Research Data Spec acts as a Subject Matter Expert in data management, mentoring and providing guidance to others on the team. This role 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.

Requirements

Bachelor's degree and 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

Assists in conducting quality checks of data accuracy with data source records as assigned.
Reviews medical records for prospective clinical trial patients in conjunction with study eligibility parameters to assist with enrollment.
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 study binders and filings according to protocol requirements and department policy.
Prepares source documentation logs for review by trial investigators by extracting information from available source documents.
Updates data and safety related information in OnCore and collaborates with the trial investigators for review and submission to the applicable sponsor(s) and regulatory authorities.
Maintains screening, enrollment, and other sponsor and/or protocol specific logs.
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.