UNIV - Program Coordinator II - DCU Project Management Director - Department of Public Health Sciences - MUSC
Charleston, SC
About the Job
Job Description Summary
The Program Coordinator II will serve as the Project Management Director for assigned DCU studies.The Data Coordination Unit, housed within the Department of Public Health Sciences (DPHS) at the Medical University of South Carolina, specializes in providing assistance with the design of clinical trials and analysis of their data and in establishing, implementing and maintaining data and project management systems for multicenter clinical trials.
DCU Project Management Directors are responsible for overseeing all study-specific project management activities for their assigned trials. This includes, but is not limited to, overseeing all on-site monitoring activities, monitoring informed consent forms, ensuring regulatory documents are collected and maintained according to GCP guidelines, and leading internal monitoring meetings.
Entity
Medical University of South Carolina (MUSC - Univ)Worker Type
EmployeeWorker Sub-Type
Research GrantCost Center
CC001038 COM PHS Operations CCPay Rate Type
SalaryPay Grade
University-06
Pay Range
Scheduled Weekly Hours
40Work Shift
Job Description
Job Duties & Responsibilities:
1. 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%)
2. 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%)
3. 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%)
4. 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%)
5. 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%)
6. Direct and oversee study drug distribution, safety reporting, the collection of regulatory and essential documents, and the activities of external site monitors. (10%)
Minimum Experience and Training Requirements:
A bachelor's degree and two years relevant program experience.
Preferred Experience & Additional Skills:
A bachelor’s degree and at least two years relevant clinical research experience. A master’s degree in a related field is preferred.
Additional Job Description
Minimum Requirements: A bachelor's degree and two 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 lower objects, up to 15 lbs., from height of 36 inches to floor level, 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 determine distance/relationship between objects; depth perception. (Frequent) Good peripheral vision capabilities. (Continuous) Ability to maintain hearing acuity, with correction. (Continuous) Ability to perform gross motor functions with frequent fine motor movements. (Frequent)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.
Medical University of South Carolina participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
