Under general supervision, the IRB Assistant is primarily responsible for the pre-reviewing and analyzing of all research project applications to ensure compliance with Institutional Review Board (IRB) policies and procedures, Federal regulations, and ethical guidelines for the protection of human subjects. Additional duties include preparing the monthly IRB meeting agenda, attending the monthly IRB meeting, documenting IRB decisions, drafting meeting minutes, and preparing IRB determination letters. The IRB Assistant serves as a main point of contact for researchers and other key research personnel who make submissions to the IRB for review, offering guidance and instruction on the IRB application process and the use of the web-based IRB management system IRBNet. This position operates in a primarily remote capacity, with an expectation of in-office presence approximately one day per week.

Education

Associate of Arts degree OR

Individuals continuing their studies to get Bachelor’s degree with 60 hours of semester credits completed in Healthcare field..

Experience

0 - (2) years’ experience working with an Institutional Review Board and/or Human Research Protection Program preferred.

Candidates without experience is welcome, training will be provided.

Skills

• Ability to learn and possess a basic knowledge of the core Federal regulations for the protection of human subjects in research (U.S. Code of Federal Regulations Title 45 Part 46 and Title 21 Parts 50 and 56).
• Strong computer skills with experience using Microsoft Word, Excel, and Outlook.
• Ability to learn and master a web-based IRB management system (IRBNet).
• Possess a working knowledge of virtual meeting environments (e.g. Webex) to include the ability to screen share.
• Detail oriented with a high degree of accuracy and reliability.
• Excellent oral and written communication skills.
• Ability to give effective instructional guidance both orally and in writing.
• Possess a strong knowledge of medical terminology.
• Ability to multi-task, set priorities, and manage time effectively.
• Ability to meet deadlines.
• Ability to function independently and work alone for long periods of time.
• Ability to effectively work in a remote environment.

Principal Duties and Responsibilities

• Pre-reviews and analyzes all research project submissions received via the IRB electronic management system (IRBNet) for completeness and to ensure compliance with GBMC IRB standard operating policies and procedures, applicable Federal regulations, and ethical guidelines for the protection of human subjects.  Notifies and works with the appropriate individual when a submission is incomplete or requires modifications and verifies that the required modifications have been made.
• Prepares the monthly IRB meeting agenda in IRBNet by assigning submissions to the appropriate agenda, placing the items in agenda order, and writing a comment for each agenda item.
• Sends monthly meeting reminders to IRB members, confirming attendance at the monthly meeting and making sure the required quorum can be met.  Confirms the attendance of individuals making new project presentations.
• Makes primary reviewer assignments for the monthly IRB meeting and notifies IRB members accordingly.
• Attends the monthly IRB meeting via Webex, greeting members and guests as they join the meeting, recording attendance, and overseeing the technical portion of the meeting to include screen sharing the meeting agenda with attendees for the duration of the meeting.
• Documents in IRBNet, after each monthly meeting, the decisions and/or actions made by the IRB.
• Documents project closures by updating recorded data in both IRBNet and the master project spreadsheet in Microsoft Excel.
• Prepares a draft of the monthly IRB meeting minutes in IRBNet.
• Prepares IRB determination letters in IRBNet after each monthly meeting.
• Prepares and deposits all review fee payments, including both external checks and internal department money transfers.
• Pre-reviews submissions qualifying for expedited review by the IRB Chairperson to include the drafting of determination letters.
• Updates and maintains the “GBMC Investigators Required to Submit Annual FCOI Statements and Their Corresponding Studies” list in Microsoft Word and master spreadsheet in Microsoft Excel.
• Prepares, tracks, and obtains IRB member annual, signed conflict of interest statements.
• Assists with not-for-cause and for-cause post-approval monitoring audits.

All roles must demonstrate GBMC Values:

Respect

I will treat everyone with courtesy. I will foster a healing environment.

• Treats others with fairness, kindness, and respect for personal dignity and privacy
• Listens and responds appropriately to others’ needs, feelings, and capabilities

Excellence

I will strive for superior performance in every aspect of my work. I will recognize and celebrate the accomplishments of others.

• Meets and/or exceeds customer expectations
• Actively pursues learning and self-development
• Pays attention to detail; follows through

Accountability

I will be professional in the way I act, look and speak. I will take ownership to solve problems.

• Sets a positive, professional example for others
• Takes ownership of problems and does what is needed to solve them
• Appropriately plans and utilizes required resources for various job duties
• Reports to work regularly and on time

Teamwork

I will be engaged and collaborative. I will keep people informed.

• Works cooperatively and collaboratively with others for the success of the team

Addresses and resolves conflict in a positive way

• Seeks out the ideas of others to reach the best solutions
• Acknowledges and celebrates the contribution of others

Ethical Behavior

I will always act with honesty and integrity. I will protect the patient.

• Demonstrates honesty, integrity and good judgment
• Respects the cultural, psychosocial, and spiritual needs of patients/families/coworkers

Results

I will set goals and measure outcomes that support organizational goals. I will give and accept help to achieve goals.

• Embraces change and improvement in the work environment
• Continuously seeks to improve the quality of products/services
• Displays flexibility in dealing with new situations or obstacles
• Achieves results on time by focusing on priorities and manages time efficiently

Pay Range

$19.92 - $29.87

Final salary offer will be based on the candidate's qualifications, education, experience and alignment with our organizational needs.

Equal Employment Opportunity

GBMC HealthCare and its affiliates are Equal Opportunity employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity and expression, age, national origin, mental or physical disability, genetic information, veteran status, or any other status protected by federal, state, or local law.