UNIV - Research Program Coordinator II - Department of Medicine: Division of Infectious Diseases

UNIV - Research Program Coordinator II - Department of Medicine:
Division of Infectious Diseases

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Job Description Summary Under the direct supervision of the MUSC-based Principal Investigator, the Research Program Coordinator II (PCII) will work with a study team located in South Africa to ensure rigorous conduct of clinical research trials of new therapeutics for tuberculosis. This position will involve international travel, mainly to South Africa. The duration and frequency of international travel is estimated at one 7-to-10-day trip approximately every 4 months, on average.

This position requires independent decision‑making and a high degree of professionalism.

Entity Medical University of South Carolina (MUSC - Univ)
Worker Type Employee
Worker Sub-Type Research Grant
Cost Center CC000972 COM DOM Infectious Diseases CC
Pay Rate Type Salary
Pay Grade University-06
Pay Range $47,588.00 - $67,817.00 - $88,047.00
Scheduled Weekly Hours 40
Work Shift Full-time

• 25% - Lead an integrated quality management/quality assurance program for tuberculosis clinical trials conducted at the clinical site in South Africa. Implement processes for monitoring study quality and progress, with emphasis on mycobacteriology laboratory results. Oversee that protocol‑prescribed processes are being implemented and adhered to among all sites. Work with study team members to identify and resolve quality issues that are encountered.
  
  This will require periodic international travel to the study site as well as regular phone/email communications with study team members.
• 20% - Perform regular quality control for reported test results from the mycobacteriology laboratory to ensure accuracy and validity of reported results.
• 20% - Serve as a liaison between the sponsor and the study team in South Africa in order to address issues and facilitate implementation of the clinical trial(s). Lead regular video meetings between the sponsor, MUSC team, and South Africa‑based teams.
• 10% - Collaborate with the South Africa‑based regulatory manager to prepare regulatory submissions to the South Africa‑based ethics committees.
• 5% - Organize and prepare regulatory submissions to the MUSC IRB. Serve as the main point of communication with the MUSC IRB.
• 5% - Manage and perform study‑specific training for international site teams. This may include on‑site training at the international study site and/or remote (e.g. web‑based) training.
• 5% - Participate in semi‑annual meetings and other activities required by the sponsor (US Centers for Disease Control and Prevention).
• 5% - Maintain appropriate certifications and credentials. Conduct all research in adherence with the FDA Code of Federal Regulations "Good Clinical Practices" as well as MUSC IRB regulations.
• 5% - Other duties as assigned which includes general duties to include answering phones, copying, filing.

• At least 2 years of experience with study coordination and submissions to Institutional Review Boards/Ethics Committees.
• Experience working in international settings is preferred.
• Knowledge of tuberculosis is highly desirable.

A bachelor's degree and two years of relevant program experience.

Ability to perform job functions in an upright position. Ability to perform job functions in a seated position. Ability to perform job functions while walking/mobile. Ability to work indoors. Ability to work outdoors in all weather and temperature extremes. Ability to work in confined/cramped spaces. Ability to perform from kneeling positions. Ability to squat and perform job functions. Ability to perform 'pinching' operations.

Ability to fully use both hands/arms. Ability to perform repetitive motions with hands/wrists/elbows and shoulders. Ability to reach in all directions. Possess good finger dexterity. Ability to maintain tactile sensory functions. Ability to lift and carry 15 lbs., unassisted. Ability to lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted. Ability to push/pull objects, up to 15 lbs.,

unassisted. Ability to maintain 20/40…