Human Subject Res Coord II

Rochester, NY

Responsibilities

Summary:

This position supports the Cardiology Division as a research coordinator in pharmaceutical and device clinical trials. Typical duties will include but are not limited to: conducting study protocols as the primary coordinator, with responsibility for study start-up activities such as WIRB and RSRB submissions, recruitment and enrollment and entire conduct of given study under the direction of the Principal Investigator. Ensures compliance with all applicable regulatory and institutional requirements and standards as well as compliance with Good Clinical Practice (GCP) guidelines and sponsor requirements. On-call responsibilities are expected, dependent on individual study protocols. This position will assist the administrative efforts of the Manager/Senior Health Project Coordinator and Director of the Research to assess clinical feasibility of newly proposed projects, evaluating study protocols regarding standard of care and research oriented tasks, evaluating time and effort needed to complete clinical tasks and study procedures and visits related to conduct of the studies toward assessment and preparation of budgets for the studies. This person will be committed to providing high quality research efforts on the Cardiology Division's behalf.

Responsibilities:

  • Conducts visits to ensure research participant adherence with protocol requirements. Dispensing of investigational medications and devices, performing procedures as required by protocols (obtaining lab specimens, performing electrocardiograms, collecting data while observing electrophysiology, diagnostic, interventional cardiology procedures, exercise testing, drawing of bloods, etc.).

  • Recruiting/screening/consenting/enrollment of patients, record reviews and interviews. Reviews medical chart history with PI to verify inclusion criteria are met before enrollment

  • Coordinates the administrative details required to initiate and conduct human subject research, such as IRB submissions and regulatory document collection.

  • Receiving, distributing, and explaining study information, including protocol, and human subject recruitment materials 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, trains staff on details of protocol, including inclusion and exclusion criteria, informed consent procedures, study activities, process for source documentation and case report form (CRFs) completion, and adverse event reporting.

  • Filling out case report forms, creating patient instructions and calendars, scheduling patient appointments, and assisting the investigators as needed.

  • Prepares for, participates in and serves as a liaison for sponsor monitoring visits. Develops good working relationship with sponsors to foster a positive research environment and attend study Investigator/Coordinator meetings as required for study start-up.

  • Collection and Reporting of adverse and serious adverse events to sponsor.

Other duties as assigned

Requirements:

  • Bachelor’s degree in a health-related field required

  • 3 year of experience in human subject research coordination required;

  • or equivalent combination of education and experience required

  • Experience as Human Subject Research Coordinator I experience

  • Word processing and data analysis software required

  • Clinical skills in phlebotomy, EKG’s and cardiac stress testing preferred

  • Professional Research Coordinator Certification (SoCRA or ACRPP 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: $ 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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