Clinical Research Data Spec I

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Job Location (Full Address):

220 Hutchison Rd, Rochester, New York, United States of America, 14620

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400178 Cancer Center/Clin Trials Ofc

Work Shift:

Range:

UR URG 106 H

Compensation Range:

$21.36 - $29.90

The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

Responsibilities:

Assists in creating, updating, and maintaining research charts and case report forms, including regulatory related issues, in accordance with department standard operating procedures. Coordinates with the Principal Investigators (PI), staff, and sponsor-designated contacts to resolve data inquiries as needed. 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. Answers simple data clarifications (i.e. data queries) for each study.

Schedule 8 AM-5 PM Responsibilities GENERAL PURPOSE: The Clinical Research Data Specialist I assists in creating, updating, and maintaining research charts and case report forms, including regulatory related issues, in accordance with department standard operating procedures, under the supervision of the senior team members. Under guidance, this position 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. This position 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. RESPONSIBILITIES: Under the guidance of the senior team members, extracts 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 Works closely with and under the guidance of the senior team members Partners with the primary CRC, CRN, and Technical Associates Under guidance, coordinates with the primary and sub-investigators to ensure data accuracy. Manages a workload of studies commensurate to level of experience Answers simple data clarifications (i.e. data queries) for each study. Under guidance, answers more complex data clarifications (i.e., data queries) for each study. Schedules and meets with study monitors and ensures 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 to ensure accurate source documentation. Assures clinical issues from monitoring reports are addressed and closed out before the next monitoring visit. Assures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines. Under guidance, prepares data status update reports to be presented routinely at PI Oversight meetings Under the guidance of the CRDM and DCIII, extracts and prepares drug safety profile information for annual reports. Under guidance, prepares relevant information for DSMC reports as required and requested. Under supervision, maintains 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. Under guidance, 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). Under guidance, updates data and safety related information in OnCore (e.g., Serious Adverse Event reports) in accordance wit