UNIV - Research Program Coordinator II - Journeyman - Department of Neurosurgery
MUSC Health · Charleston, SC · 1 mo ago
On-siteOTHRFull-time
Job Duties
- Review all research protocols, submissions, and required documents for submission and approval.
- Prepare budgets for each project for submission to appropriate funding sources and the MUSC Office of Research Programs, ensuring they meet all IRB and FDA requirements.
- Care for the reporting and communications with the IRB, government agencies, and study sponsors regarding adverse effects, study implementations, study renewals, study terminations, study close-outs, and other necessary activities.
- Maintain quality assurance of the assigned projects, adhering strictly to protocol requirements.
- Liaison between investigators, sub-sites, and sponsors.
- Data management according to protocol requirements and protocol compliance, including collecting and recording all data pertaining to study patients on specific studies and submitting it on time to research bases.
- Maintain up-to-date knowledge of the status of current studies and review, evaluate, and report to the PI on a monthly basis.
- Coordinate journals for references, assist in protocol development, and disseminate data.
- Data entry and producing clean data as required by sponsors in a timely manner.
- Liaison between the patient and the PI regarding consent forms for patient enrollment and scheduling of treatments in accordance with protocol timelines.
- Collaborate with all members of the research team in developing and implementing strategies for the effective management of the research studies.
- Coordinate with nurses, techs, and other hospital ancillary services to ensure the success of study milestones.
- Implement recruitment and enrollment strategies for the division, assist Program Manager in handling multicenter trials, and communicate with sub-sites about contractual agreements, start-up site documents, training, and clean data production.
- Participate in conference development such as agendas, minutes, and other required documents for successful meetings.
- Continuously examine and evaluate the effects of the research regimen on study subjects and contribute to the advancement of services provided to them in promoting health education and communication.
- A research team advocate to take the department and division to the next level of research mission.
- Participate in department research activities as required.
- Attend meetings and conferences required by the protocols.
Minimum Requirements
- A bachelor's degree and three years of relevant program experience.
Physical Requirements
- Continuous: Perform job functions in an upright position, perform job functions in a seated position, walk/move around, work indoors.
- Frequent: Perform job functions while walking/mobile, work indoors, work outdoors in all weather and temperature extremes, work in confined/cramped spaces, perform job functions from kneeling positions, perform job functions by squatting, perform 'pinching' operations, fully use both hands/arms, perform repetitive motions with hands/wrists/elbows and shoulders, reach in all directions, possess good finger dexterity, maintain tactile sensory functions, lift and carry 15 lbs., unassisted, lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted, push/pull objects, up to 15 lbs., unassisted, maintain 20/40 vision, corrected, in one eye or with both eyes, see and recognize objects close at hand, see and recognize objects at a distance, determine distance/relationship between objects; depth perception, good peripheral vision capabilities, maintain hearing acuity, with correction, perform gross motor functions with frequent fine motor movements.