Human Subject Research Specialist II

Location: Northern

## Human Subject Research Specialist IIApplylocations:
Rochester - NYtime type:
Full time posted on:
Posted Todayjob requisition :
R273701

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.
** Job Location (Full Address):
** 220 Hutchison Rd, Rochester, New York, United States of America, 14620
** Opening:
** Worker Subtype:

Regular Time Type:

Full time Scheduled Weekly

Hours:

40

Department:400094 Neurology - NMD M & D

Work Shift:

UR - Day (United States of America)
Range:

UR URG 108 HCompensation Range:$25.14 - $35.24
* 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:
** The Study Coordinator will coordinate clinical research projects involving patients with muscular dystrophy, in specific, myotonic dystrophy. These projects include clinical trials evaluating genetic therapies targeting the root cause of the disease and observational studies, e.g., leveraging a remote research platform developed by the DM research team. The study coordinator will assist in enhancing and expanding the remote research platform.

The Study Coordinator II will work as an integral part of the research team, assisting the principal investigator, communicating with study participants, and the broader DM community. This role mentors Human Subject Research Coordinator I(s) and supervises students as assigned.
** ESSENTIAL FUNCTIONS
*** Coordinates, schedules, and conducts research study visits in accordance with the protocol to support the 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 the protocol’s procedures. Resolves questions and concerns received from study subjects, triaging to the Principal Investigator as necessary. Coordinates and schedules appointments and works with multidisciplinary teams.

Performs testing, including timed mobility tests and questionnaire administration and creates shipments of biological materials. Assists with study start-up activities including budget development, ancillary approvals, and the creation of study materials. Monitors changes in patients’ health and performs safety reporting and follow-up. Maintains patient charts and facilitates study monitoring with sponsors and contract research organizations.
* Assist in remote research platform management. This includes monitoring equipment sent to and from study participants, cleaning and preparing equipment for shipment, and facilitating remote patient blood sample collection.
* Uses independent clinical judgement to recruit, consent, enroll, and retain study subjects across human subjects’ studies. Develops, implements, and evaluates subject recruitment and retention strategies. Creates and modifies patient recruitment material as necessary. Leads patient recruitment initiatives and community outreach initiatives, such as participation in patient conferences.  Manages and updates registries used for subject recruitment.
* Ensures adherence to regulatory requirements for research studies.  Manages IRB submissions to include study applications, amendments and continuing reviews.  Creates, modifies, organizes, and maintains study documentation for the regulatory file. 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.
* Mentors and trains NMD Study…