Human Subject Research Spec I

Rochester, NY

GENERAL PURPOSE:

Coordinates the activities associated with human subject research and data management for geriatric oncology clinical research activities and studies.

JOB DUTIES AND RESPONSIBILITIES:

  • Coordinates the administrative details required to initiate and conduct human subject research, such as, receiving, distributing, and explaining study information, including protocol, and human subject recruitment materials (i.e., brochures, advertisements, newsletters, etc.) to immediate team members and relevant others.

  • Ensures all immediate and extended team members understand and adhere to all aspects of all approved protocols, procedures and standards for documentation and communication. Under general direction from the Principal Investigator and senior research staff members, trains staff on details of protocol, including inclusion and exclusion criteria, informed consent procedures, study activities, process for source documentation, and adverse event reporting. Reviews and documents the dispensing and returning of study materials. Ensures additional training is provided to ensure changes to protocol and documents are communicated and adhered to.

  • Assists with evaluating and assessing older patients with cancer in the geriatric oncology clinics at HH and elsewhere. Learns and implements geriatric assessment, as these are critical inputs for recruitment from our clinic to geriatric oncology studies.

  • Assists in human subject recruitment and screening activities, including reviewing study site patient databases and office records for patients that meet the protocol inclusion criteria. May participate in developing recruitment strategies. May conduct telephone interviews to screen potential study candidates. Reviews medical chart history to verify inclusion criteria are met before enrollment. May travel to the various regional sites for recruitment (Elmira, Dansville, Batavia, Geneva, Canandaigua, Greece, Hornell, Olean, Brockport, and Wellsville)

  • Conducts visits to ensure research participant adherence with protocol requirements such as proper use of device and/or other interventional activities; to conduct qualitative interviews with participants; to document adverse events and report to senior study staff, Principal Investigator (PI), Institutional Review Board (IRB), Sponsor and/or any other required recipients or entities; and to ensure all data are collected and secured within approved parameters and procedures.

  • Organizes data collection and data management activities through transcribing and coding qualitative data, building databases for quantitative data (REDCap), and participating in activities reviewing quality of data. Presents at team meetings. Participates in analysis and organizing of study reports and scientific communication (e.g., presentations, manuscripts)

  • Acts as liaison with Sponsor’s Monitor: to provide data clarifications, to review study protocols, to ensure thorough understanding and communication, to respond to questions that arise during the study, to communicate and document adverse events as advised by the Principal Investigator, and to ensure regulatory and other documents (such as consent forms and CRFs) are complete, accurate and available for review. Communicates with Sponsor to clarify data queries to determine report format.

Other duties as assigned

QUALIFICATIONS:

  • Bachelor's degree required.

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

  • Knowledge of word processing and data analysis software preferred.

  • MoCA - Certification within 3 months of employment.

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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