Clinical Research Coordinator - Neurology

University of Kansas Medical Center • Kansas City, MO

1d

About The Position

The Clinical Research Coordinator in the Department of Neurology is responsible for working collaboratively with multidisciplinary teams, research and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of clinical research. This position will manage clinical research studies by coordinating and participating in a variety of complex activities involved in the scheduling, collection, compilation, documentation and analysis of clinical research data. The Clinical Research Coordinator will monitor participants’ progress including documenting and reporting adverse events and participate in periodic quality assurance audits of protocols.

Requirements

• Four (4) years of relevant experience. Education may substitute for experience on a year for year basis.
• Six (6) months’ experience in clinical research, or equivalent.
• Experience in regulatory, FDA codes and guidelines for Good Clinical Practices.
• Experience with regulations governing clinical research (CFR, GCP, HIPAA)
• Experience with statutes and guidelines relevant to regulatory affairs in clinical research.
• Experience with study budgets, review contracts, and grant applications.

Nice To Haves

• Bachelors’ degree.
• Six (6) years of relevant experience.
• Experience in Neurology, preferably with people with Huntington’s disease.
• Communication
• Organization
• Presentation
• Interpersonal skills
• Time management
• Attention to detail

Responsibilities

• Recruit, evaluate, and educate participants and/or caregivers for clinical trials in collaboration with the clinical research team.
• Conduct informed consent interviews following The University of Kansas Health System (TUKHS) Standard Operating Procedures (SOP), including use of surrogate consent forms when required for cognitively impaired participants.
• Document trial-related activities per regulatory requirements in a timely and accurate manner.
• Coordinate all aspects of study visit activities, including scheduling hospital-based procedures such as MRIs, PETs, ECGs, lab draws, IV infusions, lumbar punctures, and dispensation of study medication.
• Maintain trial regulatory documentation, including correspondence with sponsors, the KUMC Human Subject Committee, and study participants.
• Collect and verify accurate medical history and concomitant medication information from participants and/or caregivers to ensure eligibility and compliance with trial specifications.
• Monitor participants, in consultation with caregivers as needed, for any changes in health; document new symptoms and report potential adverse events to the Principal Investigator (PI).
• Assist physicians in cerebrospinal fluid (CSF) collection, including participant and/or caregiver education, preparation of sterile supplies, support during the procedure, aliquoting specimens for storage/transport, and post-procedure follow-up with participants.
• Prepare local and central lab requisitions to ensure proper testing of CSF, blood, and urine samples.
• Prepare and ship biological specimens to central labs in compliance with regulatory requirements.
• Conduct interviews with participants and/or caregivers regarding mood, anxiety, neurobehavioral symptoms, and functional abilities.

Benefits

• Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan.
• Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available.
• Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays.
• One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment.
• A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level