Clinical Research Coordinator - Neurology

Department: SOM KC Neurology - Neuromuscular ----- Neuromuscular Staff Position Title: Clinical Research Coordinator - Neurology Job Family Group: Professional Staff Job Description Summary: The Clinical Research Coordinator in the Department of Neurology works with multidisciplinary teams including patients/ study participants, families, physicians, and administrative staff to coordinate all aspects of clinical trial activities within the Neuromuscular Disease Program. 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. Job Description: Job Duties Recruit, evaluate, and educate participants and/or caregivers regarding clinical trials related to neuromuscular disease in collaboration with the clinical research team. Conduct informed consent interviews with participants and caregivers following Neuromuscular Program Standard Operating Procedures (SOP) for obtaining consent, including determining when surrogate consent is required due to cognitive impairment. Document trial-related activities in a timely and accurate manner in accordance with regulatory requirements. Coordinate all aspects of study visit activities for participants and caregivers, including scheduling hospital-based procedures such as MRI, PET, ECG, lab draws, IV infusions, lumbar punctures, clinical assessments, and dispensation of study medication. 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 status throughout the clinical trial. Document new symptoms or health changes and report potential adverse events to the Principal Investigator (PI). Based on the PIs determination, prepare adverse event (AE) reports for sponsors and the Institutional Review Board (IRB) when required. For serious adverse events (SAEs), prepare and submit FDA MedWatch or sponsor-provided safety reports to regulatory authorities within required reporting timelines. Assist physicians with cerebrospinal fluid (CSF) collection for clinical trials by educating participants and caregivers regarding the lumbar puncture procedure, preparing sterile lumbar puncture supplies, assisting during the procedure while maintaining sterile technique, aliquoting CSF into protocol-specified vials for storage and transport, providing post-procedure care instructions, and conducting follow-up with participants to assess for potential adverse events. Prepare local and central laboratory requisition forms to ensure appropriate testing of CSF, blood, and urine specimens. Prepare, package, and ship biological specimens to central laboratories in accordance with protocol and regulatory requirements. Conduct interviews with participants and/or caregivers regarding mood, anxiety, neurobehavioral symptoms, and functional abilities. Ensure study staff complete required protocol training and maintain documentation of training compliance. Facilitate investigator review of diagnostic and laboratory results, including EMG, ECG, MRI, PET, and other study-related tests, and assist with communication of clinically relevant findings to participants and their primary care providers when appropriate. Maintain study documentation, including participant research records, updated protocols, and regulatory binders. Prepare adverse event and protocol deviation reports for submission to the IRB. Assist regulatory staff with preparation of IRB submissions, including new study applications, continuing review submissions, consent form updates, and protocol amendments. Ensure study data are entered into sponsor-provided and/or internal KU databases according to sponsor requirements, typically within three business days following data collection. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, tasks, duties, and assignments. Furthermore, job duties, responsibilities and activities may change at any time with or without notice. Required Qualifications Work Experience Four (4) years of experience in basic science or health related field. Education may be substituted for experience on a year for year basis. Experience working with patients, families, physicians, and administrative staff. Preferred Qualifications Education: Bachelor's degree in basic science or health related field. Certifications/Licenses: SOCRA CCRP certification. Work Experience Research experience. Experience with electronic medical records. Experience in Neurology and/or Neuromuscular research. Skills Attention to detail Time management Interpersonal skills Multitasking Computer skills Required Document Resume/CV Cover letter Comprehensive Benefits Package: 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. https://www.kumc.edu/human-resources/benefits.html Employee Type: Regular Time Type: Full time Rate Type: Salary Compensation Statement: The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above. Pay Range: $60,800.00 - $91,200.00 Minimum $60,800.00 Midpoint $76,000.00 Maximum $91,200.00 The mission of the University of Kansas Medical Center is to improve lives and communities in Kansas and beyond through innovation in education, research, and health care. The University of Kansas 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, gender expression, national origin, ethnicity, ancestry, age, protected veteran or disability status, marital status, parental status, or genetic information. http://policy.ku.edu/IOA/nondiscrimination https://kumc-publicpoliciesandprocedures.policystat.com/policy/8446235/latest/ Under Kansas state law, certain KUMC positions are subject to disability preference. For positions subject to this requirement, KUMC will offer an interview to a person who has applied for an open position who is qualified, with or without reasonable accommodation, to meet the performance standards of the position and who has presented acceptable proof of disability. If the position you apply for is subject to the disability preference requirement, you will be asked to provide information in support of your request for disability preference when you complete the application for employment. https://www.kumc.edu/public-safety/clery-information/annual-security-report.html https://www.e-verify.gov/sites/default/files/everify/posters/EVerifyParticipationPoster.pdf https://www.laborposters.org/federal/1606-federal-pay-transparency-poster.htm