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MUSC Health · 2 months ago

UNIV - Program Coordinator II - DCU Project Management Director - Department of Public Health Sciences

Charleston, SC

Full-time

Onsite

Entry, Mid Level

$48K/yr - $88K/yr

2+ years exp

The Medical University of South Carolina (MUSC Health) is seeking a Program Coordinator II to serve as the Project Management Director for assigned DCU studies. This role involves overseeing all study-specific project management activities, ensuring compliance with regulatory guidelines, and providing guidance to collaborators throughout the project lifecycle.

Health CareHospitalMedical

Responsibilities

Serve as the Project Management Director for assigned DCU studies. Direct, implement, oversee, and manage all study specific project management activities for assigned projects. Provide comprehensive guidance and direction to collaborators pertaining to project management issues. (25%)

Assess project management procedures with a focus on risk in accordance with the FDA policies and guidance on centralized monitoring and ICH Good Clinical Practice guidelines, and implement changes to ensure high quality trial conduct. (25%)

Lead and direct the development of trial specific procedures related to Project Management activities and responsibilities. Coordinate the development and maintenance of study specific documents, including, protocols, informed consent forms, and manual of procedures. (20%)

Review program objectives to determine compatibility with agency's mission; assess programs and propose policy or procedure changes. Provide direction and guidance to staff concerning program issues. Participate in the management of the assigned studies; attends planning sessions, recommend allocation of resources, provide feedback to employees and agency head. (10%)

Prepare and present project management reports to the Operations Committee as well as sponsor and federal agencies as requested. Respond to requests for information from the PI and sponsor. (10%)

Direct and oversee study drug distribution, safety reporting, the collection of regulatory and essential documents, and the activities of external site monitors. (10%)

Qualification

Clinical ResearchGCP GuidelinesProject ManagementFDA PoliciesCommunication SkillsTeam Leadership

Required

A bachelor's degree and two years 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 job functions 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 vision, corrected, in one eye or with both eyes

Ability to see and recognize objects close at hand

Ability to see and recognize objects at a distance

Ability to determine distance/relationship between objects; depth perception

Good peripheral vision capabilities

Ability to maintain hearing acuity, with correction

Ability to perform gross motor functions with frequent fine motor movements

Preferred

A bachelor's degree and at least two years relevant clinical research experience

A master's degree in a related field is preferred

Company

MUSC Health

MUSC Health provides health-care services through its patient- and family-centered care, education, research, and various partnerships. It is a sub-organization of Medical University of South Carolina.

Founded in 1824

Charleston, South Carolina, USA

10001+ employees