Institutional Review Board Coordinator - PRN - Varies - Research Dept

DHR Health - US:TX:Edinburg - Varies

Summary:

FLSA STATUS: Exempt Non-Exempt

MISSION STATEMENT:

Our Mission is to improve the well-being of those we serve with a commitment to excellence: every patient, every encounter, every time.

VISION:

Our Vision is to create a world-class health system to advance medicine and increase access for the communities we serve by empowering caregivers to heal through compassion, knowledge, innovation, integrated care and excellence.

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 EDUCATION/ QUALIFICATIONS:

• 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.

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.

Responsibilities:

POSITION RESPONSIBILITIES:

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.
• 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.

Other information:

LINES OF REPSONSIBILITIES:

(Chain-of-command)

1. Vice President

CUSTOMER SERVICE:

Provide excellent customer service to all DHR customers. All employees are required to attend the DHR C.A.R.E.S program which outlines the Customer Service Principals including: Commitment, Accountability, Respect, Excellence and Service.

AGE SPECIFIC:

Employees must be able to demonstrate the knowledge and skills necessary to provide care appropriate to the age of the patients served in his/her assigned unit. The individual must demonstrate knowledge of principles of growth and development over the life span and possess the ability to assess data reflective of the patient’s status and interpret the appropriate information needed to identify each patient’s requirement relative to his or her age.

AMERICANS WITH DISABILITIES ACT: (ADA):

A. Essential Duties: Indicated by bold print within performance standards, preceding individual numbered criteria.

The following table provides physical requirements that will be associated with, but not limited to, this position:

B. Working Conditions: The individual spends over 95% of his/her time in an air-conditioned environment with varying exposures to noise. There is protection from weather conditions but not necessarily from temperature changes. The position does have low exposure to malodorous, infectious body fluids from patients and some minimal exposure to noxious smells from cleansing agents.

C. Occupational Exposure: This position has minimal to no exposure to blood, body fluids, or tissues and is an OSHA Category III (although situations can be imagined or hypothesized under which anyone, anywhere, might encounter potential exposure to body fluids). Person who performs these duties are not called upon as part of their employment to perform or assist in emergency medical care or first aid or to be potentially exposed in some other way.

D. Aptitudes: HIGH 1 2 3 4 5 6 LOW

Intelligence: General learning ability: The ability to “catch on” or understand instructions and underlying principles. Ability to reason and make judgments. 3

Verbal: Ability to understand meanings of words and ideas associated with them, and to use them effectively. To comprehend language, to understand relationships between words, and to understand meanings of whole sentences and paragraphs. To present information or ideas clearly. 3

Numerical: Ability to perform arithmetic operations quickly and accurately. 2

Spatial: Ability to comprehend forms in space and understands relationships of plane and solid objects. Frequently described as the ability to “visualize” objects or two or three dimensions, or to think visually of geometric forms. 2

Form Perception: Ability to perceive pertinent details and objects or in pictorial or graphic material to make visual comparisons and discriminations and see slight differences in shapes and shadings of figures and widths and lengths of lines. 3

Clerical Perception: Ability to receive pertinent details and verbal or tabular material. To observe differences in copy, to proofread words and numbers, and to avoid perceptual errors in arithmetic computation. 2

Motor Coordination: Ability to coordinate eyes and hands to fingers rapidly and accurately in making precise movements with speed. Ability to make a movement response accurately and quickly. 3

Finger Dexterity: Ability to move hands easily and skillfully. To work with fingers in placing and turning motions. 3

Manual Dexterity: Ability to move hands easily and skillfully. To work with hands in placing and turning motions. 3

Eye-Hand-Foot Coordination: Ability to move the hand and foot coordinately with each other in accordance with visual stimuli. 3

Color Discrimination: Ability to perceive and respond to similarities or differences in colors, shapes, or other values of the same or different color. To identify a particular color, or to recognize harmonious or contrasting color combinations, or to match color adequately. 3

I have read and reviewed my job description with my supervisor or designee and I understand the job I am expected to perform.

If applicable ____________ certification will be completed within _________ time frame of hire/transfer date.

Employee Signature: ________________________________ Date: ____________________

Transfer/Hire Date Effective: ________________________.