UNIV - Clinical Research Assistant - Department of Medicine: Division of Pulmonary

Medical University of South Carolina • Charleston, SC

2d • $37,944 - $60,690 • Onsite

About The Position

The Clinical Research Assistant is responsible for visit coordination, careful pharmacy and laboratory management, support for both inpatient and outpatient research patient visits, as well as general administrative and technical support to the program and staff.

Requirements

• A high school diploma and three years of relevant program experience.
• A bachelor's degree may be substituted for the required program experience.

Nice To Haves

• 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 lift objects, up to 15 lbs., from floor level to height of 36 inches, 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 hear and/or understand whispered conversations at a distance of 3 feet.
• Ability to perform gross motor functions with frequent fine motor movements.
• Ability to work in dusty areas.

Responsibilities

• Responsible for meticulous and careful pharmacy and laboratory management for clinical trials, including receiving study drug and/or device shipments, managing IVRS/IWRS/IXRS forms, documenting receipt, dispensation, return, destruction and quarantine of investigational product/devices, monitoring temperature control, acting as the Investigational Drug Services (IDS) liaison, providing education on the pharmacy process, and meeting and reviewing pharmacy documentation with research monitors. This includes preparing IP accountability files, reconciling and resolving action items, preparing lab kits, monitoring lab kit inventory, discarding expired kits, monitoring/ordering general lab supplies, and managing lab requisitions. Maintain and update laboratory binders.
• Works with the Recruitment Team with prescreening potential subjects for clinical trials, understanding study criteria, identifying eligible trials, reviewing medical records to confirm inclusion and exclusion criteria, contacting and scheduling potential subjects, and providing information about trials.
• Assists research coordinators and management with subject-related activities including escorting research patients, conducting minor visits, transporting research supplies, performing clinical assessments (EKG, PFT, 6MWT, vitals monitoring), data entry, processing/storing/shipping laboratory specimens, completing subject reminder phone calls, rescheduling appointments, retrieving external medical records, completing initial medical history review, and managing shipments of study related items. Assist in phone study visits, scheduling research patients, managing the COVID-19 research email inbox, preparing and sending research shipments, and conducting inventories for COVID-19 trials.
• Provides research administrative support to research protocols and staff, including supporting regulatory team members, assisting with events, meetings, and trainings by scheduling rooms, arranging catering, taking minutes, and making copies. Daily sorting, delivery, and stocking of mail, shipments, and faxes; providing phone coverage; tracking inventory of supplies. Serves as liaison to CRO/sponsor visitors, preparing binder carts, ensuring monitor supplies are available, working with CRO/sponsor representatives to resolve discrepancies, and collecting binder carts and investigational product/devices. Maintains, inventories, and archives program equipment and resources by scheduling calibration, setting up new equipment, logging items, troubleshooting equipment, addressing day-to-day issues, tracking storage of completed studies, building binders, and filing documents.
• Perform other duties as required.

Benefits

• Medical University of South Carolina participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED