Human Subject Res Coord I

Rochester, NY

Responsibilities

JOB DESCRIPTION:

Provide support to the overall coordination of the funded and non-funded clinical studies within EIOH. The individual must be able to work independently with minimal supervision. Excellent interpersonal skills, writing skills, and computer skills are required. Knowledge of Recap required. Knowledge of RSRB policies, procedures and submission process extremely helpful.

RESPONSIBILITIES:

  • Acts as liaison with various departments involved in study to provide data clarifications, reviews study protocols, ensures thorough understanding and communication, responds to questions that arise during the study, communicates and documents adverse events as advised by the PI and ensures regulatory and other documents, such as consent forms and CRFs, are complete, accurate, and available for review. Communicates with study team/PI to clarify data queries to determine report format.

  • Coordinates the administrative details required to initiate and conduct human subject research, including receiving, distributing and explaining study information, such as protocol and human subject recruitment materials, to immediate team members and relevant others.

  • Reviews and documents the dispensing and returning of study materials, such as study drugs and devices. Ensures additional training is provided to ensure changes to protocol and documents are communicated and adhered to. Responsible for safe transport and logging of clinical specimens delivered to laboratories.

  • Provide data clarifications; respond to questions that arise during study activities; communicate and documents adverse events as advised by the Principal Investigator; ensure regulatory and other documents (such as consent forms and CRFs) are complete, accurate, and available for review and quality assurance.

  • Enters study data and ensures for completeness of data and/or performs the duplicate data entry. Analyze data collected by research studies. Assist the PI or other team members in the development, research, compilation and editing of presentations and publications of study findings. Run Redcap reports as requested by study team and PI.

  • Keep current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures and guidelines, and make recommendations. Demonstrate accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines. Keep current with industry standards, best practices, trends in therapeutic areas relevant to research studies, and then make recommendations and implement changes as appropriate.

Other duties as assigned.

QUALIFICATIONS:

  • Bachelor’s degree candidate

  • 1 years of experience in human subject research coordination; or an equivalent combination of education and experience required.

  • Proficiency with Microsoft Office 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: $ 18.89 - $ 26.44 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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