Utilization Review Coordinator jobs in Mcallen, TX

POSITION SUMMARY: The Doctors Hospital at Renaissance Institutional Review Board (DHR IRB) Coordinator/Specialist will coordinate all incoming research activities through the DHR IRB. Successful candidate will serve as the primary regulatory resource for all research investigators submitting research studies to the DHR IRB and will ensure that all research and studies are conducted in compliance with federal and state regulations, DHR Health system policies and DHR Research Institute policies relating to Human Subject Research.

POSITION RESPONSIBILITES: In support of research protocols, the IRB coordinator/specialist will be required to fill the following responsibilities:

• Coordinate all new IRB submission through the DHR IRB management system to ensure consistency, completeness and compliance with all state and federal regulations. Current DHR IRB management system is IRBNet. Knowledge with IRBNet is highly preferred but not required.
• Coordinate all continuing review submissions through the DHR IRB management system to ensure consistency, completeness and compliance with all state and federal regulations.
• Review all completed project submissions, determine review type, recommend assignment of reviewers, and recommend exempt status.
• Communicate to Principal Investigators items that require clarification, or documents required for submission, to complete a research application for IRB review.
• Send correspondence to Principal Investigators to communicate the decisions of the IRB
• Evaluate reports of unanticipated problems, amendments and continuing review forms
• Provide direct guidance (but not supervision), and serve as a resource, to co‐workers in the IRB office, DHR Research Institute and DHR-affiliated entities.
• Monitor the regulatory environment and recommend changes, as needed.

In support of IRB administrative duties and responsibilities, the IRB coordinator/specialist will be required to fill the following responsibilities:

• Coordinate a team approach to produce the monthly IRB agenda for each meeting and ensure that materials are distributed within established guidelines and time frames.
• Work with other members of the team, attend IRB meetings, record deliberations, and write meeting minutes. Ensure that minutes for each meeting are accurately recorded; finalize minutes for submission to DHR Medical Staff Office.
• Assist in developing, recommending, and implementing policies and procedures to enhance efficiency of committee operations and general office functions.
• Maintain up to date IRB written procedures.
• Assist with training and orientation tasks of new committee members.

The IRB Coordinator shall perform the following additional functions, as needed, in support of Institutional Review Board operations:

• Maintain collaborative team relationships with peers, colleagues and customers in order to effectively contribute to the working group’s achievement of goals and help to foster a positive work environment.
• Attend seminars, workshops and conferences in order to gain insight into new trends in human research and to learn new approaches for the application of federal regulations.
• Participate in, or present at, research‐related education sessions to DHR research community.
• Work collaboratively with the IRB Chair and Vice President of Research and Development to facilitate ongoing development, implementation and maintenance of the DHR human subject’s protection program.

JOB KNOWLEDGE/EXPERIENCE: The successful candidate will have a strong background in human subject research compliance and knowledge with codes of federal regulations 45 CFR 46.111 and 21 CFR 56.111. Candidate must display knowledge in the various types of research activities; criteria for approval associated with each category and are able to communicate effectively to the DHR research community of such rules and regulations.

• A minimum of a Bachelor’s degree with 2 years with IRB management and coordination.
• Must possess excellent written and verbal skills, as well as demonstrate independence and initiative
• Must have knowledge of, and experience in the interpretation of Federal and State regulations especially pertaining to human subject research in biomedical research.
• Highly proficient with relevant computer programs and software.
• Ability to handle multiple activities simultaneously and to effectively prioritize tasks and responsibilities.
• Must possess discretion and mature judgment as confidential information is routinely encountered.