Job Description Summary

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Job Description

Job Duties:

25% - Provides oversight as lead of a specific disease portfolio. Works with Principal Investigators and Program Leadership to ensure that disease portfolio is meeting goals. Tracks projects to ensure timelines are met. Troubleshoots any hurdles that come up. Develops research-based workflows for projects within the clinics for assigned disease. Onboards new projects to the disease portfolio by working with Program Leadership on start-up activities. Runs portfolio team meetings with staff assigned to the area. Identifies staffing needs for the disease portfolio. Serves as primary point of contact with sponsors and CROs.

25% - Oversee the day-to-day clinical and operational activities required for the successful execution of research protocols. Ensure that all study procedures are conducted in strict accordance with the protocol, regulatory requirements, and institutional standards. Responsibilities include (but not limited to) obtaining informed consent, coordinating, and scheduling study visits, educating participants about study procedures, monitoring and reporting adverse events (including preparation of serious adverse event reports), collecting and processing laboratory specimens, dispensing investigational products, reviewing patient diaries, completing required study procedures, entering data, and completing case report forms, and maintaining accurate and compliant study documentation.

15% - Prepares for and participates in team meetings. Serves as a primary liaison between Sponsor, PI, vendors, sub-contracts, and ancillary services including Investigational Drug Services Pharmacy, labs, imaging, NEXUS, and MUSC Hospital services. Ensures connection between services is working and troubleshoot as needed for projects.

10% - Acts as the database expert for the Program by ensuring that all databases are up to date and current by meeting required timelines.  Also provides training, support, and guidance as needed for databases.

10% - Supervise and mentor junior clinical research staff. Provides disease specific training to junior staff and orients them to workflows for the disease portfolio. Trains and acts as resource on job related tasks and research best practices. Works alongside the Program Leadership to ensure junior staff are conducting trials within guidance.

10% - Creates a recruitment plan in compliance with federal regulations and institutional policies. Prepares materials to report research progress back to Program leadership and the PI. Organizes and coordinates community outreach programs and patient support groups as needed. Participates in external community and patient programs as requested to advertise research.

5% - Other duties as assigned by the program leadership. Will serve as back-up to other staff as needed in the Program.

Additional Job Description

Minimum Requirements: A bachelor's degree and two years of 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.

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