Human Sub Research Spec II

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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.

Responsibilities:

ESSENTIAL FUNCTIONS

• Uses independent clinical judgement to recruitment, consent, enroll and retain study subjects across the NMD portfolio of human subjects’ studies. Develops, implements, and evaluates subject recruitment and retention strategies (i.e. display boards, pamphlets, patient referral program, and other in-office advertising initiatives). Creates and modifies patient recruitment material as necessary. Leads patient marketing/recruitment initiatives and community outreach initiatives such as participation in health fairs, community events and all activities to enhance department visibility and ability to attract potential patients for current and future clinical research trial participation. Manages and updates registries used for subject recruitment.
• Coordinates, schedules, and conducts research study visits according to the protocol to support successful achievement of milestones, specific aims, and study objectives. Performs study related procedures as outlined in the protocol. Training will be provided where necessary to implement protocol’s procedures. Coordinates and documents dispensing and returning of study drugs/materials.  Resolves questions and concerns received from study subjects, triaging to Principle Investigator as necessary. Ensures patient clinical care resources are available to support conduct of human subject studies in accordance with protocol.  Coordinates and schedules appointments, and works with multidisciplinary teams for the provision of additional needed resources. Inputs/regularly updates and reviews all patient information in the patient databases to ensure the most accurate databases possible. Performs testing such as timed mobility tests, sensory testing, questionnaire administration, image analysis, (Meissner corpuscles), electrophysiologic assessments, interrater reliability studies of image analysis. Performs microscopy and data analysis of epidermal nerve fibers depending on the protocol.
• Mentors and trains NMD Study Coordinators (HSRC I) on activities related to conducting human subject research and provides back-up support across the team as needed. Directs, understands, implements, and provides training on most recent study protocol (e.g., amended protocol), procedures, documentation, and use of study materials to subjects and team members as appropriate.  Ensures compliance, following up and communicating as needed. Keeps current with study-specific training, including understanding specific details of study protocol, all relevant sponsor and institutional policies, standard operating procedures, and guidelines. Troubleshoots and resolves operational issues related to studies.
• Develops, modifies and maintains regulatory requirements for multiple research studies.  Manages IRB submissions to include study applications, amendments and continuing reviews.  Creates, modifies, organizes, and maintains study documentation for the regulatory file. Ensures consistency and standardization of protocol activities across multiple sites. Responsible for monitoring compliance with all regulatory and institutional policies, and takes corrective action on issues identified.  Trains on federal, state, sponsor, and/or institutional regulations, policies, and practices related to human subject research.
• Serves as the liaison between cross-functional research team, additional research sites, research administration, study sponsors, and IRB to facilitate communication, resolves issues, and enhance collaboration. Works with research administration team on pre-award and study start up documents providing expertise related to time studies and budget feasibility for study procedures, overall complexity and effort required for completing studies. Reviews study progress, including communicating with research administrator and updating OnCore or other workbooks on enrollment, visits, and other study procedures completed to ensure maximum payment is received and expenses are monitored in accordance with budget. Represents the University and Principle Investigator at study meetings as needed. Schedules, prepares for, and attends study sponsor monitor meetings in accordance with protocol.
• Develops and/or manages databases for research studies.  Ensures data is entered in a timely manner and database(s) is up-to-date.  Exports research data used for analysis and preparation of presentations, abstracts, and publications.  Develops, implements, and monitors systems and methods to ensure data integrity.  Assist in chart abstraction for the maintenance of patient databases.
• Demonstrates accountability for continuous learning related to clinical research. Attends training sessions and other educational opportunities related to clinical research in order to keep current with Good Clinical Practice guidelines, federal and state polices and laws, institutional certifications, industry standards and best practices, and trends in relevant therapeutic areas. Participates in monthly study team meetings and provides updates on project status and changes in regulatory requirements as needed.
• Other duties as assigned

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree and 2 years of experience in human subject research coordination required
• Or equivalent combination of education and experience
• Experience as Human Subject Research Coordinator I preferred
• If applicable, department specific experience required
• Experience as a Phlebotomist preferred

KNOWLEDGE, SKILLS AND ABILITIES

• Word processing and data analysis software required

LICENSES AND CERTIFICATIONS

• SOCRA - Certification In Clinical Research upon hire preferred
• Association of Clinical Research Professionals (ACRP) upon hire preferred

The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture 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 characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.