Clinical Research Coordinator - Neurology

Clinical Research Coordinator - Neurology

Department: SOM KC Neurology - Neuromuscular

Position Title: Clinical Research Coordinator - Neurology

Job Family Group: Professional Staff

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-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.

The Clinical Research Coordinator position is responsible for recruiting, evaluating, and educating patients regarding clinical trials related to neuromuscular disease. This position coordinates all aspects of assigned research studies including recruitment, study visit activities according to protocol, maintenance of the investigator site file, data entry, and other various tasks. The Coordinator collaborates with multidisciplinary teams, research, and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of clinical research.

This role manages assigned clinical research studies by supervising a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. Monitors study participants' progress including documenting and reporting adverse events. Participates in periodic quality assurance audits of protocols. This position will be or become familiar with neuromuscular disease and conducting research according to ICH GCP guidelines.

The position requires an individual with exceptional communication skills and the ability to multi-task to work collegially with members of the neuromuscular research team to ensure research studies are being conducted according to protocol.

• 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 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 Med Watch 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…