Clinical Research Data Spec I

Rochester, NY

GENERAL PURPOSE:

Under the direction of the senior staff of the assigned clinical trial, assists in creating, updating, and maintaining research charts and case report forms, including regulatory related issues, in accordance with department standard operating procedures. Under supervision from these senior level staff, coordinates 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. 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:

Under the guidance, inspects clinical data and research data from electronic records and other sources and assists study staff on entering this data into electronic medium for each assigned study

  • Works closely with and under the guidance of the assigned management

  • Partners with the Sponsor and Study personnel (internal and external to the UoR) to support the collection and analysis of research protocols.

  • Under the guidance of the assigned management, 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 the guidance of assigned management, 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 the guidance of the assigned management, prepares data status update reports to be presented routinely at Study oversight meetings.

  • Under the guidance of the assigned management, extracts and prepares drug safety profile information for annual reports.

  • Under the guidance of the assigned management, prepares relevant information for Safety and Monitoring reports as required and requested.

Under supervision, maintains logs, and investigates and reports on data collection into an electronic data capture system (eDC) in a timely manner according to protocol guidelines and department SOPs:

  • Maintains required electronic Trial Master files (eTMF) electronic documentation according to protocol requirements and department policy.

  • Under the guidance of the assigned management, prepares reporting 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 (e.g., eDC, external medical assessment records (EKG, Labs), other available sources).

  • Under the guidance of the assigned management, updates data and safety related information in eDC system (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, as required by protocol and department SOPs.

Under supervision, maintains and electronic files necessary to support clinical research.

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.

QUALIFICATIONS:

  • Associate’s degree required.

  • Bachelor’s degree preferred.

  • 1 year of relevant experience or equivalent combination of education and experience required.

  • 1 year of clinical research or health care relevant experience preferred.

  • Skill in completing assignments accurately and with attention to detail 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 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.

  • Ability to understand and follow standard research protocols and procedures preferred.

  • Medical terminology knowledge preferred.

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.

How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

Pay Range

Pay Range: $20.92 - $29.29 Hourly

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.

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Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
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