Clin Research Data Spec II

at  University of Rochester

QUALIFICATIONS:

• Bachelor’s degree required
• 1 year of relevant work experience, 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
• 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
• Highly collaborative, works well in teams required
• Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet required
  The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create - and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.

GENERAL PURPOSE:

Under the direction of the senior staff, the Clinical Research Data Specialist II (CRDS II) exhibits increased learned skills and flexibility in performing duties, and assumes responsibility for the data management of clinical research protocols. With minimal supervision, and latitude for independent judgment, the CRDS II will coordinate with the investigational faculty (both Principal and Sub-Investigators), clinical trial office staff, and sponsor-designated contacts (e.g., Clinical Research Associates; CRAs) to resolve data inquiries as needed. With minimal supervision and latitude for independent judgment, the CRDS II will formulate and organize data entry plans to manage assigned caseloads. The CRDS II 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.

PRIMARILY RESPONSIBLE FOR EXTRACTING CLINICAL DATA AND RESEARCH DATA FROM ELECTRONIC MEDICAL RECORDS AND OTHER SOURCES AND ENTERS THIS DATA IN THE CLINICAL PAPER-BASED OR ELECTRONIC DATA CAPTURE SYSTEM FOR EACH ASSIGNED STUDY

• Partners with the primary CRC to provide data status reports, and ensure protocol data objectives are scheduled appropriately
• Manages a workload of studies commensurate to level of experience
• Answers data clarifications (i.e. data queries) for each study.
• Schedules and meets with study monitors and assures patient cases are ready for each monitor visit and items are addressed after each monitoring visit.
• 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.
• Exhibits increasingly sound judgment in planning/performing data entry and reporting of research protocols for optimal quality research.
• 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.
• Develops a basic understanding of some processes specific to Finance and Regulatory operations which are impacted by trial data reporting, and is able to articulate their components effectively.

PRIMARILY RESPONSIBLE FOR MAINTAINING LOGS AND ONCORE SYSTEM IN A TIMELY MANNER ACCORDING TO PROTOCOL GUIDELINES AND DEPARTMENT SOPS:

• Maintains study binders and filings according to protocol requirements and department policy.
• Prepares source documentation logs (e.g., Adverse Events, Concomitant Medications, Medical History, Disease Response, etc.) for review by trial investigators by extracting this information from available source documents (e.g., eRecord, external medical records, other available sources).
• With minimal guidance from the senior staff, updates data and safety related information in OnCore (e.g., Serious Adverse Event reports), 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.