Human Subject Res Coord II

Rochester, NY

GENERAL PURPOSE:

We are looking for a research coordinator who is self-motivated, committed to excellence, humble, hardworking, as well as a team player to join the geriatric hematology and oncology team to help improve lives of older adults with blood cancer through researching behavioral and supportive care interventions. As a research coordinator, you will coordinate activities associated with human subject research and data management.

JOB DUTIES AND RESPONSIBILITIES:

  • Represents sites, providers, study team, patients, study participants and the University to develop, monitor and maintain working relationships, positive communications and effective results with regard to the coordination of human subjectstudies.Supportsthecontacts and relationshipsbetween and amongPrincipal Investigator (PI), research staff, study sites and sponsoring and regulatoryagencies.

  • Ensurescompliancewith all applicableregulatory and institutionalrequirements and standards. Ensures the integrity and security of all study data at all times. Initiates, monitors and ensuresthat all protocolactivitiesarestandardizedacross study sites.

  • Implements immediate and appropriate corrective action when inconsistency of activities is identified.

  • Performs regulatory activities which may include but not limited to writing and submitting protocols to the IRB, creating study materials (e.g., consent forms, study forms.)

  • 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. Conduct telephone interviews to screen potential study candidates. Reviews medical chart history to verifyinclusioncriteriaare metbeforeenrollment. May travel to Highland Hospital forrecruitment.

  • Manages ongoing studies. Develops workflows, oversees study procedures, manages study participants, develops and maintains recruitment flowcharts, maintains study files per SOP, protocol, and site instructions.

  • Manages REDCap study databases and performs quality checks across all databases.

  • Performs qualitative data analyses and analyzes data for novel research findings. Works with statisticians to compile and clean study data.

  • Writes and edits scientific manuscripts for journal submission. Creates figures from study data, prepares manuscripts for submission, writes and submits abstracts, presents study findings at conferences, performs systematic and literature reviews. Assists with grant preparation.

  • Trains research coordinators and other staff on activities associated with conducting human subject research specific to study protocols and generally in compliance with Good Clinical Practice (GCPs) guidelines and sponsor requirements. Trains/onboards human subject research coordinators to perform various physical and cognitive assessments (e.g., SPPB, MOCA). Trains coordinators on the

  • following software: MAXQDA, REDCap, SAS, Adobe Acrobat Pro. Mentors human subject research coordinators.

  • 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.

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

  • Experience as Human Subject Research Coordinator I preferred.

  • Knowledge of word processing and data analysis software preferred.

  • Professional Research Coordinator certification (SoCRA or ACRP) 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: $45,800 - $64,100 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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