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University of Rochester Human Subject Research Coordinator - 227949 in Rochester, New York

Human Subject Research Coordinator Job ID 227949

Location Strong Memorial Hospital Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening

Full Time 40 hours Grade 051 Physical Medicine & Rehab

Schedule

8 AM-4:30 PM; LIMITED WKNDS

Responsibilities

POSITION SUMMARY:

Coordinates the activities associated with human subject research. Provides assistance to the Principal Investigator and works as an integral part of the research team .

SPECIFIC RESPONSIBILITIES:

Coordinates the administrative details required to initiate and conduct human subject research, such as, receiving, distributing, and explaining study information, including protocol, and human subject recruitment materials (i.e., brochures, advertisements, newsletters, etc.) to immediate team members and relevant others, as follows:

Ensures all immediate and extended team members understand and adhere to all aspects of all approved protocols, procedures and standards for documentation and communication. Under general direction from the Principal Investigator, trains staff on details of protocol, including inclusion and exclusion criteria, informed consent procedures, study activities, process for source documentation and case report form (CRFs) completion, and adverse event reporting. Keeps current with study-specific training. (15%)

Recruits, schedules, and conducts subject visits for research studies in accordance with study protocols, coordinating these visits with the Principal Investigator. May perform activities including but not limited to medical chart review, participant consent, telephone interviews, vital signs, cognitive assessments, or mobility tests, as required by protocol. Works with ancillary service departments to schedule drug dispensing, lab assessments, and/or study imaging. Resolves questions and concerns received from study subjects, triaging to the Principal Investigator as necessary. (35%)

Develops and/or manages databases for research studies. Develops, implements, and monitors systems and methods to ensure data integrity. Ensures data is entered in a timely manner and database(s) is up-to-date. Responds to queries resulting from research visits in a timely manner, ensuring all issues are resolved. Exports research data used for analysis and preparation of presentations, abstracts, and publications. (20%)

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 Principal 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%)

Attends training sessions and other educational opportunities related to clinical research in order to keep current with Good Clinical Practice (GCP) guidelines, federal and institutional policies and laws, industry standards and best practices, and trends in relevant therapeutic areas; makes recommendations as appropriate. Maintains current CITI credentials for Human Subject Protection, GCP, Clinical Research Coordinator, plus additional sponsor GCP certifications as required. (5%)

QUALIFICATIONS:

Required: Bachelor’s degree and 1 year of experience in human subject research coordination; or equivalent combination of education and experience.

Preferred: Knowledge of word processing and data analysis software preferred. Excellent organization, time management, and problem-solving skills. Strong communication, writing, and interpersonal skills. Ability to read, interpret, and apply complex regulations, policies, and requirements for each study assigned. Exhibits professionalism and ability to work both independently and collaboratively as part of a team in a diverse environment.

How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

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