Clinical Research Coordinator - Neurology (Neuromuscular)

Department

SOM KC Neurology - Neuromuscular ----- Neuromuscular Staff

Position Title

Clinical Research Coordinator - Neurology (Neuromuscular) Job Family Group: Professional Staff

Job Description

Summary: The Clinical Research Coordinator 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. Through careful and well-planed 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.

Job Description

Job Duties Recruits, evaluates, and educates patients regarding clinical trials related to neuromuscular disease. Conducts Informed Consent Interview with participant and caregiver following Neuromuscular. Program Standard Operating Procedures (SOP) for obtaining consent from cognitively normal and cognitively impaired individuals. Follows SOP for determination of when use of a Surrogate consent form is necessary, due to extent of cognitive impairment. Documents trial related activities per regulatory requirements in a timely and accurate manner. Coordinates of all aspects of study visit activities for patients and families, including scheduling of hospital-based procedures such as MRI and PET, and other procedures to include clinical study visit interviews and assessments, ECG, lab draws, IV infusions, lumbar punctures, and dispensation of study medication. Gathers accurate medical history and concomitant medication information and ensures that medical conditions and medications meet trial specifications. Probes patient/ caregiver for any changes in health throughout clinical trial intervention and monitors for potential adverse events. Obtains complete reports of new symptoms/changes in health conditions and reviews with clinician/principal investigator. Based on principal investigator’s determination of adverse event (AE) qualification, prepares formal AE report for sponsor and for IRB, when applicable per regulations. If AE meets criteria of Serious Adverse Event (SAE), prepares full FDA MedWatch or sponsor-provided Safety Report and submits to regulatory authorities within 24 hours of learning of event. Assists physician in cerebrospinal fluid (CSF) collection for clinical trials by educating patient / caregiver regarding the lumbar puncture procedure, preparing lumbar puncture supplies, providing supplies to physician during procedure while maintaining sterile field, aliquoting CSF by protocol-specified amounts into separate vials for storage and transport, instructing patient/caregiver in post-lumbar puncture care and expectations, conducting follow –up phone call to determine if any adverse events were experienced. Prepares local and central lab requisition forms to ensure proper testing is conducted on CSF, blood, and urine samples. Prepares and ships biological specimens to central labs per protocol and regulatory requirements. Conducts interviews with patient and/or caregiver regarding mood, anxiety, neurobehavioral symptoms, and functional abilities. Ensures all study staff complete required training for proper conduct of the trial. Ensures investigator’s timely review of lab tests, EMG/ECG/MRI/PET results and communicates clinically relevant information to patient and patient’s primary care doctor as appropriate. Ensures availability of medical records, updated subject records and updated protocols. Updates and maintains regulatory binders. Prepares adverse event reports and protocol deviation reports for submission to IRB. Assists 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. Ensures all study data is entered into sponsor-provided and/or internal KU databases per sponsor requirements, typically within 3 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. Work Environment Will occasionally travel to attend national meetings. Required Qualifications Work Experience: Four (4) years of relevant work experience. Relevant education may substitute for experience on a year for year basis. Experience working with patients, families, physicians, and administrative staff.