UNIV - IRB Program Manager I - Office of Research Integrity

Job Description Summary

This position is responsible for assisting with the development, implementation, and management of the MUSC Institutional Review Board (IRB) quality program. Quality Assurance (QA)/Quality Control (QC) administrator supports three MUSC IRBs. Attaining and maintaining comprehensive and up-to-date knowledge of human subject research protections and IRB regulations as contained in 45 CFR 46, 21 CFR 50 & 52, AAHRPP Standards and Elements and other applicable regulations is essential. The Administrator facilitates the proper conduct of human subject’s research for studies conducted across MUSC including the regional health networks. The position requires advanced knowledge of research regulations, guidance, and practice standards as well as the ability to apply this knowledge across a diverse portfolio of research that includes studies managed by the internal IRB as well as those studies where MUSC relies on an external IRB.

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type​

Classified

Cost Center

CC002115 Office Of Research Integrity (ORI)

Pay Rate Type

Salary

Pay Grade

University-07

Pay Range

57,334.00 - 81,707.00 - 106,080.000

Scheduled Weekly Hours

40

Work Shift

Job Description

30% - Assist in the development of IRB quality assurance activities for internal department use. Write QA/QC reports to capture the QA/QC activities that have been completed and that are ongoing.  Perform quality control checks for all three IRBs.  Consisting of but not limited to conducting quality control of IRB approval letters sent from the IRB to researchers; IRB meeting minutes for regulatory elements, IRB member/representation; IRB regulatory determinations.

15% - Under general direction assist in the development, implementation, and monitoring of short and long-term projects. Plans goals and objectives focused on achieving the IRB’s mission, strategic plan, and MUSC Enterprise priorities.

15% - Proactively evaluates IRB staff and IRB member review processes that can contribute to errors. Assist in developing guidance documents/checklists for use by the IRB staff, IRB chairs, and IRB members.

10% - Depending on assignment, conduct pre-review and tracking of new research proposals; processing of amendments and continuing reviews of existing research protocols; and reportable events. May also involve meeting facilitation and recording of meeting minutes, and/or education and outreach; contributing to training of new staff members and new IRB members as assigned.

10% - Responsible for assigned aspects of the AAHRPP re-accreditation process.

10% - Manages internal SOP portfolio for the IRB office. Assist in creating and revising departmental SOPs and HRPP policies. Manages IRB approval template letters.

10% - Serves as an eIRB liaison in the IRB office. The liaison administers, maintains, and supports the eIRB system from the IRB side of eIRB. The liaisons serve as the primary contact for problem resolution and functions as the IRB’s representative with MUSC local collaborators as well as national user groups.  The liaison is charged with supporting, maintaining and assisting in developing new functionality of the eIRB system. Ongoing tasks include but are not limited to registration of new users and update existing users in the eIRB system; Troubleshoot issues and responses to investigators as well as IRB staff; Attend monthly meetings (in person as needed) and conference calls between the collaboration members; Contributes to revising current eIRB system and smartforms to increase efficiency and functionality. Under the direction of the IRB Manager and ORI Director the liaison explores, introduces, and implements strategies and tools to make best use of current and future technologies to maintain the most efficient electronic system.

Additional Job Description

Minimum Requirements: A bachelor's degree and three years relevant program experience. Physical Requirements: (Note: The following descriptions are applicable to this section: Continuous - 6-8 hours per shift; Frequent - 2-6 hours per shift; Infrequent - 0-2 hours per shift) Ability to perform job functions in an upright position. (Frequent) Ability to perform job functions in a seated position. (Frequent) Ability to perform job functions while walking/mobile. (Frequent) Ability to work indoors. (Continuous) Ability to work outdoors in all weather and temperature extremes. (Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to perform job functions from kneeling positions. (Infrequent) Ability to squat and perform job functions. (Infrequent) Ability to perform 'pinching' operations. (Infrequent) Ability to fully use both hands/arms. (Frequent) Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent) Ability to reach in all directions. (Frequent) Possess good finger dexterity. (Continuous) Ability to maintain tactile sensory functions. (Continuous) Ability to lift and carry 15 lbs., unassisted. (Infrequent) Ability to lift objects, up to 15 lbs., from floor level to height of 36 inches, unassisted. (Infrequent) Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent) Ability to maintain 20/40 vision, corrected, in one eye or with both eyes. (Continuous) Ability to see and recognize objects close at hand. (Frequent) Ability to see and recognize objects at a distance. (Frequent) Ability to match or discriminate between colors. (Frequent) Ability to determine distance/relationship between objects; depth perception. (Frequent) Good peripheral vision capabilities. (Continuous) Ability to maintain hearing acuity, with correction. (Continuous) Ability to hear and/or understand whispered conversations at a distance of 3 feet. (Frequent) Ability to perform gross motor functions with frequent fine motor movements. (Frequent) Ability to work in dusty areas. (Infrequent)

If you like working with energetic enthusiastic individuals, you will enjoy your career with us!

The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need.

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