This is temporary position with pay $16.50 per hour. This position is not benefit eligible.
Hours: M - F; 8-5
This role is expected to last for a year
Under the general direction of the Chair of Ophthalmology,this position administrate and coordinate clinical research activities for theDepartment of Ophthalmology. The Clinical Coordinator assists in using clinicalexpertise and research experience to prepare and complete all required studyspecific site source documents, follow Good Clinical Practice guidelines, workclosely with investigators of assigned trials, travel to local recruitmentsites when required, perform all related procedures, and assist with trackingof research procedures and distribution of reimbursements. This position isresponsible for managing the performance of the entire trial, including but notlimited to finalizing clinical trial agreements, processing IRB applicationsand annual renewals, coordinating sponsor site visits, identifying studyparticipants, assisting the investigators with use of study drugs or device andmanaging the budget for each clinical trial.
Acts as the research liaisonbetween investigators and external collaborators.
* Responsiblefor patient recruitment, scheduling all research appointments and follow upvisits, and enhancement of research subject compliance.
* Extrapolatesclinical data from patient charts for review and organizes data in accordancewith research goals.
* Assuresaccuracy, completeness and consistency in data reported; manages data asrequired and cleans up data for analysis when needed.
* Prepares foron-site monitoring of documentation and CRF information and meets with eachmonitor from each Sponsor for assigned trials to answer questions or resolve dataor documentation related issues.
* Processingand documenting all study related communications.
* Managing andinventory of study-specific medical devices.
* Prepares studyrelated medications (intravenous, subcutaneous, intramuscular) and monitors foradverse reactions, reviews laboratory results, answer study queries, andresolves study issues.
* Oversees orperforms processing, storing, and/or shipping of all study related specimens
* Works withUniversity Clinical Health or other locations as coordinator in performingclinical trials to schedule appropriate rooms for research subjectappointments/visits, rooms for site or monitoring visits, etc.
* Providesin-services or training for ancillary staff or other personnel, as needed.
* Creation ofneeded study and site source documents for new projects.
* Preparationof IRB applications and submissions; provides oversight of IRB applications andsubmissions if performed by other research personnel, assists with initial consentlanguage and ensures accuracy in consent forms.
* Prepares forinternal or external site/monitoring visits or audits.
* Participatein online training and certification for each required module of each studyassigned
* Attendsinvestigators meetings for trials assigned
* Maintainsrecords of and primary accountability for new protocols, amendments, IB's andIRB activities/ updating Regulatory binder as needed.
* Tracks andprocesses Adverse Events (AEs) and Serious Adverse Events (SAE's) per trialassigned.
* Works closelywith the PI of each study to meet recruitment goals as required by thesponsoring company of all clinical trials assigned.
* Responsiblefor assisting in troubleshooting and problem solving as needed to address dailyproblems or issues in a consistent and efficient manner.
* Informs PIand Director of recruitment and/ or randomization of numbers, needs of projectsassigned, and unusual occurrences.
* Compilesweekly status and statistical reports compiling research findings andcompliance with protocols.
* Assists incontacting entities for needed services including pharmacy and laboratoryservices for required processing of specimens.
* Assists in obtainingcost estimates for services and logistical planning for implementation ofresearch services as related to multiple individual protocols.
* AssistsDirector in monitoring of expenditures and earned capitation dollars for eachclinical trial assigned.
Internal Number: 208126
The mission of the University of Tennessee Health Science Center is to bring the benefits of the health sciences to the achievement and maintenance of human health, with a focus on the citizens of Tennessee and the region, by pursuing an integrated program of education, research, clinical care, and public service.
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