Clinical Research Coordinator - Neurology

Department:

SOM KC Neurology - Neuromuscular

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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 PI’s 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 substit