Human Subject Research Specialist

Human Subject Research Specialist University of Rochester•3.9 Rochester, NY Job Details Full-time $21.36•$29.90 an hour 4 hours ago Qualifications Regulatory inspections Specimen collection Research ethical considerations Adverse event reporting Word processing Mid-level Administrative experience Genetics Data entry Research compliance clinical trial records management Recruiting Research administration Interviewing Medical equipment cleaning Patient recruitment Research regulatory compliance IRB compliance Associate's degree Documentation review Communication skills Full Job Description 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): 601 Elmwood Ave, Rochester, New York, United States of America, 14642

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 106 H

Compensation Range:

$21.36•$29.90 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:

Coordinates the activities associated with human subject research. HSRS I will coordinate clinical research projects involving patients with muscular dystrophy, specifically, 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 Myotonic Dystrophy research team. The HSRS I will assist in enhancing and expanding the remote research platform. They will work as an integral part of the research team, assisting the principal investigator, the project manager, and communicating with study participants.

ESSENTIAL FUNCTIONS

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. Assists in human subject recruitment for both clinical trials and remote research, 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. May conduct telephone interviews to screen potential study candidates. Reviews medical chart history with Principal Investigator to verify inclusion criteria are met before enrollment. Assist in remote research platform management. This includes monitoring equipment sent to and from study participants, cleaning and preparing equipment for shipment, and monitoring remote patient blood sample collection. Assist with data management and data integrity. Under the supervision of the project manager and PI, monitors and assists with data entry for both clinical trials and remote research. Assists with scoring of video-captured functional assessments using SOPs. Conducts visits to ensure research participant adherence with protocol requirements, such as assisting in consenting, taking of medications, proper use of device, and/or other interventional activities, to document adverse events and report to senior study staff, PI, Institutional Review Board (IRB), Sponsor, and/or any other required recipients or entities. Ensures all data is collected and secured within approved parameters and procedures. Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines, and makes recommendations. Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines. Manages the regulatory details for assigned research studies. Prepares and maintains regulatory and study documentation. Manages and submits amendments and continuing reviews for IRB approval. Ensures all regulatory requirements are met and documented. Under the supervision of the clinical trial projects manager and the PI, provides 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 Sponsor to clarify data queries to determine report format. Prepares for, participates in, and serves as liaison for scheduled Sponsor monitoring visits (i.e., pre-study inspection, initiation, on-going, and close-out visits). Other duties as assigned

MINIMUM EDUCATION & EXPERIENCE

Bachelor's degree required Or Associate's degree and completion of 6 months in the Human Subject Research Coordinator Trainee program Or equivalent combination of education and experience

KNOWLEDGE, SKILLS AND ABILITIES

Word processing and data analysis software preferred Prior experience as a Phlebotomist preferred REDCAP experience preferred

LICENSES AND CERTIFICATIONS

CLASP, SOCRA, or ACRP 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.