University of Kansas Medical Center Clinical Research Coordinator in Wichita, Kansas
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rClinical Research Coordinator
SOM KC The Alzheimer's Disease Center (ADC)
Clinical Research Coordinator
Job Family Group:
Job Description Summary:
The University of Kansas Alzheimer's Disease Center (KUADC) is a National Institute of Aging P30-designated national leader in AD research with the vision to impact the lives of every patient and family dealing with Alzheimer's in the region and across the state of Kansas through our research, education, and clinical care with the goal of finding a cure. We are a comprehensive center at the forefront of clinical trials, lifestyle intervention trials, drug and translational research and basic science research. In addition, we provide a wide variety of both public education and training opportunities for the workforce of tomorrow. Our research enables us to also provide leading edge clinical care and support for dementia caregivers.
This position works with multidisciplinary teams including study participants, physicians and other clinicians, and personal trainers to coordinate all aspects of research activities for a large-scale NIH R01-funded exercise-related clinical trial within the Alzheimer's Disease Center. Through careful and well-planned methods, this position ensures that study procedures follow the study's protocol and all applicable regulatory requirements while also ensuring research participants are treated with the utmost respect and concern for their well-being and safety.
Key Roles and Responsibilities
+ Serve as lead coordinator on large-scale NIH-funded exercise-related clinical trials
+ Supervise and direct the work of Research Assistant(s) and student(s) on the study
+ Recruits, evaluates, and educates research participants regarding the study
+ Gathers accurate medical history and concomitant medication information and ensures that medical conditions and medications meet study specifications.
+ Assures participant meets all inclusion criteria for the study and participant is capable of completing the exercise intervention per protocol.
+ Assures participant does not meet any of the exclusion criteria including determining whether participants are currently meeting physical activity guidelines and thus too active for the study.
+ Conducts Informed Consent Interview with participant following ADC Standard Operating Procedures (SOP) for obtaining consent.
+ Documents study-related activities per regulatory requirements in a timely and accurate manner.
+ Coordinates of all aspects of study visit activities for participants, including scheduling of study procedures, interviews, assessments and participant gym orientation
+ Dispensation of activity monitoring devices and data collection per protocol
+ Conducts physical performance assessments with participants to measure physical function abilities and current fitness level.
+ Ensures all study personal trainers complete required IRB compliance training.
+ Conducts initial and on-going protocol training with personal trainers at the gym
+ Observes personal trainers conducting exercise intervention training sessions with participants at the gym to assure intervention fidelity and provides trainer support.
+ Ensures investigator's timely review of lab tests, ECG/MRI/PET results and communicates relevant information as appropriate.
+ Ensures availability of medical records, updated subject records and updated protocols.
+ Ensures regulatory binders are maintained with all current required documentation per local, sponsor, and federal guidelines.
+ Prepares adverse event reports and protocol deviation reports for submission to IRB and to study sponsor.
+ Ensures all study data is entered into the study's REDCap database
+ Tracks all interactions with potential participants in the ADC's Recruitment and Eligibility database.
+ Reviews study related invoices and payment for accuracy
+ Probes participant for any changes in health throughout intervention and monitors for potential adverse events. Obtains complete reports of new symptoms/changes in health conditions and reviews with clinician/principal investigator. Follow SOPs based on principal investigator's determination of adverse event (AE) qualification.
+ Other duties as assigned by supervisor
+ Bachelor's degree in a health-related field: especially exercise science, exercise physiology or physical therapy. Strong working knowledge of fitness and exercise principles and training guidelines. Prior clinical research experience and institutional review board process.
+ TWO years of study coordination experience.
+ Ability to operate personal computer and various software packages such as Word, EXCEL, and PowerPoint.
+ Attention to detail; excellent time-management skills; strong work-ethic; self-motivated; willing to learn; good interpersonal skills; strong orga