Human Subject Res Coord I
Rochester, NY
Responsibilities
Position Summary :
The Industry-Sponsored Research Program in the Department of Emergency Medicine seeks a Human Subject Research Coordinator (HSRC) to join the research team. The HSRC will play a key role in the in the interface of patients, physicians, researchers, and external sponsors/clients. The Research Coordinator will provide essential research support and study coordination for several industry-sponsored studies in the Department of Emergency Medicine under the direction of the Principal Investigator(s).
We are looking for someone who can establish good rapport with patients of all ages and backgrounds, as well as the clinical, research, and administrative teams. The ideal candidate will show a demonstrated ability to multi-task, operate efficiently, learn and adapt quickly. Candidates should have phlebotomy training or be willing to complete training during the first three months of employment. An ability to work across the Medical Center and River campus and travel within Monroe County is necessary.
Under general direction, the HSRC is responsible for independently planning, coordinating, and executing recruitment, scheduling, and data collection for assigned studies. The HSRC will manage the daily operations for research studies and clinical trials as needed and directed. Many of the research protocols involve working with patients (children and adults) in the Emergency Department, and may also involve student-athletes, as well as community volunteers. While the work will be carried out under general supervision, the HSRC will work independently and complete delegated tasks and study procedures with human subjects independently. May serve as back-up to coordinators and members of the study team.
Specific Responsibilities :
Recruits, schedules, and conducts subject visits for research studies in accordance with study protocols. Independently complete study activities including consent, primary data collection, cognitive assessments and other study procedures as required by protocol. Works with ancillary departments to schedule imaging or other study procedures. Resolves questions and concerns received from study subjects and sponsors, triaging to the Principal Investigator as necessary.
Understands and provides training on protocols, procedures, documentation, and use of study materials to subjects and team members as appropriate. Ensures compliance, follows up and communicates as needed. Keeps current with study-specific training.
Serves as the liaison between cross-functional research teams, study sponsors, and IRB to facilitate communication, resolve issues, and enhance collaboration. Schedules, prepares, and attends study sponsor meetings in accordance with protocol and supervisor direction. Represents the University and Principal Investigator at study meetings as needed.
Supports laboratory operations, including processing/handling specimens, sample shipping, maintaining shipping logs and databases, cleanliness of lab, supply requirements for new projects, inventory levels and ordering, designing and building sample collection kits for studies, and additional duties as assigned.
Manages regulatory aspects 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. Is available and prepared for sponsor monitoring visits.
Develops and/or manages databases and case report forms (CRF’s) for assigned research studies. Ensures data is entered in a timely manner and internal/external database(s) are up-to-date.
Attends training sessions and other educational opportunities related to clinical research in order to keep current with Good Clinical Practice guidelines, federal and institutional policies and laws, industry standards and best practices and trends in relevant areas.
Performs related duties & responsibilities as assigned/requested
Qualifications :
Bachelor’s degree required
No previous experience required
Or equivalent combination of education and experience eg. an Associate’s degree and completion of 6 months in the Human Subject Research Coordinator Trainee program required.
Word processing and data analysis software required
Excellent communication skills, including written communication, is preferred.
The ideal candidate will be exceptionally organized, trustworthy, professional, assertive, and coachable preferred.
Ability to work with a wide range of constituencies, and exercise tact and discretion when interacting with faculty, administrators, colleagues, and clients preferred.
Demonstrated ability to take initiative and able to work independently with minimal supervision preferred.
Experience collecting biospecimen samples (blood, saliva, etc.), or willingness to learn, is required.
Valid driving license and reliable transportation required.
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
Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
Opening: Full Time 40 hours Grade 051 Emergency Research Admin
Schedule: 8 AM-5 PM; WKNDS AS NEEDED