Clinical Trial Unit Research Coordinator

The University of Kansas Medical Center - Kansas City, MO4.0

Full-time
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This position works with multidisciplinary teams including study participants, families, and physicians to coordinate all aspects of research activities for studies within the Alzheimer’s Disease Center. Through careful and well-planned methods, this position ensures that study procedures follow the sponsor’s protocol and all applicable regulatory requirements while also ensuring research participants and their families are treated with the utmost respect and concern for their well-being and safety.

Required Qualifications
Bachelor’s degree in basic science or health related field. Experience may substitute for degree on a year for year basis.
Ability to operate personal computer and various software packages such as Word, Excel, and PowerPoint to manage data systems
Attention to detail, time-management skills, strong work-ethic, self-motivated, willing to learn, excellent interpersonal skills
Preferred Qualifications
Prior health care and/or research experience.
Excellent communication, writing, organizational and presentation skills.
Ability to effectively interact with multidisciplinary teams including patients, families, physicians, and administrative staff.
Familiarity with electronic medical records and study databases.
Environment Office Physical Requirements Light Probation Status
Subject to the regulations of the State of Kansas, the Board of Regents and the University of Kansas Medical Center, I understand and agree that I may be subject to a probation period and during the probation period I serve at the pleasure of the Executive Vice Chancellor of KUMC and my employment may be ended at any time during that period.

Hiring Range EEO Statement
KU Medical Center is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disability status, or genetic information.

Job Duties
Description of Job Duty
Serve as lead coordinator on research studies and supervise and direct the work of Research Assistant(s) assigned to those studies.

Job Duties
Description of Job Duty
Recruit, evaluate, and educate research participants regarding studies related to Alzheimer’s disease.

Job Duties
Description of Job Duty
Conduct Informed Consent Interview with participant and caregiver following ADC Standard Operating Procedures (SOP) for obtaining consent.

Job Duties
Description of Job Duty
Document study-related activities per regulatory requirements in a timely and accurate manner.

Job Duties
Description of Job Duty
Coordinate of all aspects of study visit activities for participants and families, including scheduling of procedures, interviews and assessments, and dispensation of study medication.

Job Duties
Description of Job Duty
Prepare local and central lab requisition forms for processing.

Job Duties
Description of Job Duty
Prepare and ship specimens to central labs per protocol and regulatory requirements.

Job Duties
Description of Job Duty
Conduct interviews with participant and/or caregiver regarding mood, anxiety, neurobehavioral symptoms, and functional abilities.

Job Duties
Description of Job Duty
Ensure all study staff completes required training for proper conduct of the trial.

Job Duties
Description of Job Duty
Ensure investigator’s timely review of lab tests, ECG/MRI/PET results and communicate relevant information as appropriate.

Job Duties
Description of Job Duty
Ensure availability of medical records, updated subject records and updated protocols.

Job Duties
Description of Job Duty
Ensure regulatory binders are maintained with all current required documentation per local, sponsor, and federal guidelines.

Job Duties
Description of Job Duty
Prepare adverse event reports and protocol deviation reports for submission to IRB and to study sponsor.

Job Duties
Description of Job Duty
Collaborate with the Research Institute regulatory project manager in preparation of IRB submissions, including review of consent forms, new study and continuing review applications, and protocol amendments.

Job Duties
Description of Job Duty
Ensure all study data is entered into sponsor-provided and/or internal KU databases per sponsor requirements, typically within 3 business days following data collection.

Job Duties
Description of Job Duty
Review study related invoices and payment for accuracy.

Job Duties
Description of Job Duty
Gather accurate medical history and concomitant medication information and ensure that medical conditions and medications meet study specifications.

Job Duties
Description of Job Duty
Probe participant / caregiver for any changes in health throughout intervention and monitors for potential adverse events. Obtain 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.

Job Duties
Description of Job Duty
Other duties as assigned by supervisor.