Clin Research Data Spec II

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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 107

Compensation Range:

$47,972.00 - $67,161.00

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:

Assumes responsibility for the data management of clinical research protocols. Coordinates with the investigational faculty, clinical trial office staff, and sponsor-designated contacts to resolve data inquiries as needed. Formulates and organizes data entry plans to manage assigned caseloads. 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.

Schedule 8 AM-5 PM Responsibilities 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. JOB DUTIES AND RESPONSIBILITIES: Independently performs chart review/pre-screening for eligibility and coordination of simple clinical research protocols. - Assists in conducting quality checks for 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 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 mai