Clinical Research Data Spec I

):

275 Hutchison Rd, Rochester, New York, United States of America, 14627

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400178 Cancer Center/Clin Trials Ofc

Work Shift:

UR - Day (United States of America)

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:

Coordinates and oversees regulatory requirements of clinical research protocols. Prepares all regulatory documentation, document filing, tracking and The Clinical Research Data Specialist I (CRDS 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 Manager, Clinical Research Data (MCRD) and Sr Clinical Research Data Specialist (Sr CRDS). Under supervision from the MCRD and Sr CRDS, the CRDS I 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.

ESSENTIAL FUNCTIONS

Under guidance, 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 MCRD and Sr CRDS
• 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 guidance, 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 with protocol guidelines and department SOPs.
• Maintains screening, enrollment, and other sponsor and/or protocol specific logs.

Under supervision maintains and files source documentation

Complies with Good Clinical Practice and the Code of Federal Regulations
• 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.

Professional Development
• Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines.
• 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.
• Other duties as assigned

MINIMUM EDUCATION & EXPERIENCE
• Associate’s degree required
• Bachelor’s degree preferred
• 1 year of relevant work experience, or equivalent combination of education and experience required

KNOWLEDGE, SKILLS AND ABILITIES
• Skill in completing assignments accurately and with attention to detail required
• Ability to process and handle confidential information with discretion.
• Commitment to the University’s core values.
• Ability to work independently and/or in a collaborative environment.
• Understands and follows data integrity standards and processes.
• Strong interpersonal, communication, and organizational skills.
• Highly collaborative, works well in teams.
• Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet.
• Ability to understand and follow standard research protocols and procedures. Medical terminology knowledge preferred.

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