UNIV - Research Program Coordinator II - Journeyman - Department of Neurosurgery
About The Position
The Research Program Coordinator II–Journeyman will lead and/or oversee the implementation and day-to-day operations of multiple complex research studies or a large research grant. They will be responsible for conducting all research related activities within a portfolio of assigned clinical trials. They also work directly with patients, study staff, Principal investigators and study sponsors to ensure institutional and Internal Review Board (IRB) compliance and that the integrity of the study is maintained. Coordination and management of industry sponsored and investigator-initiated trials involving subject screening, enrollment, data collection, scheduling visits, and conducting follow up visits. They are responsible for maintaining regulatory documents, logs, and reporting adverse events and protocol deviations to appropriate agencies. This candidate will serve as a research subject matter expert or resource across research domains and areas and will have the ability to train others on and apply research regulations to a variety of scenarios.
Requirements
- A bachelor's degree and three years of relevant program experience.
Responsibilities
- Review all research protocols, submissions, and all required document for submission and approval.
- Prepare budgets for each project for submission to appropriate funding sources and the MUSC Office of Research Programs, so that they meet all IRB and FDA requirements.
- Coordinate/perform the reporting and communications with the IRB, government agencies and study sponsors regarding adverse effects, study implementations, study renewals, study terminations, study close-out and other activities necessary for exceptional performance of all studies from inception to close.
- Responsible for the Quality assurance of the assigned projects.
- Liaison between investigators, sub-sites, and sponsors.
- Coordinate proper data management according to protocol requirements and protocol compliance, i.e. collect and record all data pertaining to study patients on specific (funded or unfunded) studies and submit on time to research bases.
- Maintain up-to-date knowledge of the status of current studies.
- Review, evaluate and report to PI on a monthly basis, as to the status of each study.
- Coordinate journals for references, assist in protocol development.
- Assist in dissemination of data.
- Meeting data entry and producing clean data as required by sponsors in timely manner.
- Liaison between the patient and the PI regarding consent forms for patient enrollment and for scheduling of treatments in conjunction with protocol time lines.
- Collaborate with all members of the research team in developing and implementing strategies for the effective management of the research studies.
- Coordinate with nurses, tech, and other hospital ancillary services requirement for the successful study milestones.
- Implement recruitment and enrollment strategy for the division.
- Collaborate with other sub-sites in enrollment productivity and assist Program Manager in handling multicenter trials.
- Responsible in communication with sub-sites about contractual agreement, start-up site documents, training, and producing clean data.
- Works with Program Manager in conferences development such as agenda, minutes, and other required documents for successful meeting.
- Continuously examine and evaluate the effects of the research regimen on study subjects and contribute to the advancement of services provided to same in promoting health education and communication.
- A research team advocacy 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.
- Participate in writing and presentation of research reports and grant protocols.
- Actively pursue additional grant studies and sources of funding for continued salary support.
- Support Program Manager in newsletter or any correspondence to sub-sites.
- Review workload and operating procedure of each research study and determine priorities and workflow.
- Willing to travel and accept additional tasks as assigned by the Program Manager.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
