UNIV - Lead Clinical Research Coordinator - Department of Medicine: Division of Pulmonary

Entity: Medical University of South Carolina (MUSC - Univ)

About the role

The Lead Clinical Research Coordinator (CRC) will focus primarily on one disease area, serving as the disease-area expert and overseeing the related research portfolio.

Responsibilities

• 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 arise. 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.
• Oversees the day-to-day clinical and operational activities required for the successful execution of research protocols. Ensures that all study procedures are conducted in strict accordance with the protocol, regulatory requirements, and institutional standards. Responsibilities include:
  • 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
  • Maintaining accurate and compliant study documentation
• Acts as the database expert for the Program by ensuring that all databases are up to date and current by meeting required timelines. Provides training, support, and guidance as needed for databases.
• 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 troubleshoots as needed for projects.
• Supervises and mentors junior clinical research staff. Provides disease-specific training to junior staff and orients them to workflows for the disease portfolio. Trains and acts as a resource on job-related tasks and research best practices. Works alongside Program Leadership to ensure junior staff are conducting trials within guidance.
• 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.
• Other duties as assigned by the program leadership. Serves as back-up to other staff as needed in the Program.

Requirements

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

Physical Requirements

• Ability to perform job functions in an upright position (Frequent: 2-6 hours per shift)
• Ability to perform job functions in a seated position (Frequent: 2-6 hours per shift)
• Ability to perform job functions while walking/mobile (Frequent: 2-6 hours per shift)
• Ability to work indoors (Continuous: 6-8 hours per shift)
• Ability to work outdoors in all weather and temperature extremes (Infrequent: 0-2 hours per shift)
• Ability to work in confined/cramped spaces (Infrequent: 0-2 hours per shift)
• Ability to perform job functions from kneeling positions (Infrequent: 0-2 hours per shift)
• Ability to squat and perform job functions (Infrequent: 0-2 hours per shift)
• Ability to perform 'pinching' operations (Infrequent: 0-2 hours per shift)
• Ability to fully use both hands/arms (Frequent: 2-6 hours per shift)
• Ability to perform repetitive motions with hands/wrists/elbows and shoulders (Frequent: 2-6 hours per shift)
• Ability to reach in all directions (Frequent: 2-6 hours per shift)
• Possess good finger dexterity (Continuous: 6-8 hours per shift)
• Ability to maintain tactile sensory functions (Continuous: 6-8 hours per shift)
• Ability to lift and carry 15 lbs., unassisted (Infrequent: 0-2 hours per shift)
• Ability to lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted (Infrequent: 0-2 hours per shift)
• Ability to push/pull objects, up to 15 lbs., unassisted (Infrequent: 0-2 hours per shift)
• Ability to maintain 20/40 vision, corrected, in one eye or with both eyes (Continuous: 6-8 hours per shift)
• Ability to see and recognize objects close at hand (Frequent: 2-6 hours per shift)
• Ability to see and recognize objects at a distance (Frequent: 2-6 hours per shift)
• Ability to determine distance/relationship between objects; depth perception (Frequent: 2-6 hours per shift)
• Good peripheral vision capabilities (Continuous: 6-8 hours per shift)
• Ability to maintain hearing acuity, with correction (Continuous: 6-8 hours per shift)
• Ability to perform gross motor functions with frequent fine motor movements (Frequent: 2-6 hours per shift)

Pay

Pay Grade: University-GEN09
Pay Range: $52,100.00 - $70,300.00 - $88,600.00

Schedule

• Scheduled Weekly Hours: 40
• Work Shift: Day