Clinical Research Spec II

Rochester, NY

GENERAL PURPOSE:

A Full-time position (40 hrs/wk) in the Division of Pediatric Infectious Diseases, to conduct surveillance studies and clinical trials. This individual will assist in the planning, coordinating, implementing, monitoring, and evaluating specific clinical research studies as assigned. Day-to-day responsibilities include screening and recruitment of potential study candidates, and performing interviews, data and specimen collection, chart reviews, vaccine verifications, and data entry for gastroenteritis and respiratory infection surveillance studies under the direction of the Principal Investigator and Manager of Clinical Research. Supervision and assistance in training some HSRC-I positions performing these clinical research program activities will also be expected, under the general direction of the Principal Investigator and Manager of Clinical Research, is expected. This individual must adhere to standards, regulatory guidelines, and approved operational procedures, and work well as part of a team to ensure study participant safety and adherence to approved protocols. The ability to complete project tasks independently as requested, be comfortable with a variety of data bases, and at all times interact in a professional and positive manner in both verbal and written communications is required.

JOB DUTIES AND RESPONSIBILITIES:

Screening, recruitment, and monitoring of study subjects .

  • Screen eligible patients to make sure they meet enrollment criteria, explain study to parent and obtain informed consent when applicable.

  • Conduct study visits to ensure patient compliance with project protocol.

Information/specimen Management

  • Collection, labeling, and coordination of study specimens to be delivered to the laboratory; ensure labeling is sequential and interfaces with lab labeling system.

  • Chart review and information abstraction/recording, phone communications with families/pediatricians/staff, fax/mail as necessary as pertains to enrolled subjects at your site.

  • Data entry and integrity checks: enter data into web-based database and respond to sponsor data queries as they arise.

  • Completion of source documents: CRFs, vaccine verifications, and 2-3 follow up phone calls for AGE cohort.

Research Team Collaboration

  • Attend team meetings and conference calls as needed.

  • Interact with Project Coordinator and Research Lab Director to ensure regulatory and other documents are complete and on time.

  • Trains/onboards and supervises Human Subject Research Specialist I coordinators on activities associated with conducting human subject research specific to study protocols, on compliance with Good Clinical Practice (GCPs) guidelines, and on sponsor requirements.

  • Assist in developing recruitment strategies and monitoring target enrollment numbers.

Other duties as assigned

QUALIFICATIONS:

  • Bachelor’s degree and 1 year of relevant experience in human subject research coordination; or equivalent combination of education and experience required.

  • Clinical Research Coordinator experience and/or nursing degree preferred. Experience with specimen collection, labeling and study coordination preferred.

  • Ability to understand, follow and coordinate standard research protocols and procedures, including data integrity standards.

  • Ability to fully adhere to applicable safety and/or infection control standards required.

  • Strong interpersonal, communication, and organizational skills; highly collaborative, works well in teams required.

  • Proficient with or ability to rapidly learn software including MS Office (e.g. Word, Excel, and PowerPoint), e-mail, REDCap required.

  • Candidate must become Human Subjects certified under the HSPP program within the first week of employment required.

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: $50,752 - $71,053 Annually

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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