University of Rochester Human Subject Res Coord I - 229058 in Rochester, New York
Human Subject Res Coord I Job ID 229058Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening
Full Time 40 hours Grade 051 General Neurology UnitSchedule
8 AM-4:30 PMResponsibilities
POSITION SUMMARY :
The Neurology Study Coordinator - CNRG will work within the Department of Neurology’s Cerebrovascular and Neurocognitive Research Group (CNRG). Research areas within CNRG involve different populations with cerebrovascular disease being the common denominator. Examples include but are not limited to cerebral vascular disease associated with HIV infection or other inflammatory conditions, acute stroke and stroke recovery, vascular complications from traumatic brain injury and hypoxic/anoxic brain injury from cardiac arrest. The research projects in the group include observational studies, clinical trials, and multi-center clinical research studies. This role will be responsible for the implementation and coordination of human subject studies including patient recruitment, conducting study visits and patient database management for multiple clinical research studies. Conducts study visits associated with human subject research. Some studies enroll subjects through inpatient admissions and may require shared on-call responsibilities, which are compensated according to HR guidelines.
SUPERVISION AND DIRECTION EXERCISED:
May be responsible for training new staff/student workers as determined by Program Manager/Principal Investigator.
SUPERVISION AND DIRECTION RECEIVED:
Under the direct supervision of the CNRG Directors, with direction from the Principal Investigator(s) and Study Coordinator II of assigned studies.
BUSINESS/TECHNICAL EQUIPMENT USED:
Standard office equipment such as multi-feature ACD or smart telephone, PC, copier, printer, scanner, fax machine, and the like. Uses a variety of basic and advanced business/technical programs/applications. Includes systems such as University Financial and Accounting Systems, vendor applications such as Microsoft Office, or internally developed databases/systems. Uses OnCore CTMS system, IORA and various sponsor/CRO systems for CRFs.
As directed with latitude for independent judgement participates in recruitment, screening, consenting and enrollment of study subjects. Communicates, coordinates and schedules (via mail, email, phone, face to face) study subjects for visits providing study information and confirming appointments. Reviews study site patient databases and records for patients that meet the protocol inclusion criteria. Conducts telephone interviews to screen potential study candidates. Reviews medical chart history with Principal Investigator to verify inclusion criteria are met before enrollment. Participates in developing recruitment strategies. (20%)
Conducts research subject visits for studies in accordance with protocol, coordinating these visits with the Principal Investigator. Ensure research participant adherence with protocol requirements such as taking of medications and/or other interventional activities. Subject visits may include a brief physical, cognitive functions tests, or attending an MRI, depending on the protocol requirements. Coordinator may perform testing such as timed mobility tests and cognitive functions tests, depending on the protocol. Resolves questions and concerns received from study subjects, triaging to the Principal Investigator or Coordinator II as necessary. Inputs/regularly updates and reviews all patient information in the patient databases to ensure the most accurate databases possible including sponsor CRFs, Epic and OnCore as applicable. Develops and/or manages databases for research studies. Ensures data is entered in a timely manner and database(s) is up-to-date. (45%)
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. 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 therapeutic areas. (10%)
Serves as the liaison between cross-functional research team, study sponsors, and IRB to facilitate communication, resolves issues (e.g., resolve queries from research visits), and enhance collaboration. Schedules, prepares for, and attends study sponsor monitor meetings in accordance with protocol. Represents the University and Principle Investigator at study meetings as needed. (10%)
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. (15%)
Other duties as assigned.
Bachelor’s degree preferably in marketing, communications, life sciences, or health administration and 1 year of experience in human subject research coordination; or equivalent combination of education and experience.
Proficiency in computer software applications including Microsoft Office programs and electronic data capture (EDC) software preferred. Ability to learn and master existing department applications and future software applications and programs. Candidate should have excellent communication and organizational skills; highly persistent and energetic professional style; self-motivation and drive to reach goals/objectives.
NOTE: This document describes typical duties and responsibilities and is not intended to limit management from assigning other work as required.How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled