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 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 wellplaned methods this position ensures that study procedures follow the sponsors protocol and all applicable regulatory requirements while also ensuring research participants and their families are treated with the utmost respect and concern for their wellbeing and safety.

The Clinical Research Coordinator 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 Clinical Research 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 position 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 multitask to work collegially with members of the neuromuscular research team to ensure research studies are being conducted according to protocol.

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 hospitalbased 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 investigators 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 sponsorprovided Safety Report and submits to regulatory authorities within 24 hours of learning of event.

• 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 completes required training for proper conduct of the trial.

• Ensures investigators timely review of lab tests EMG/ECG/MRI/PET results and communicates clinically relevant information to patient and patients 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 sponsorprovided and/or internal KU databases per sponsor requirements typically within 3 business days following data collection.

• Available to travel to attend national meetings.

Required Qualifications

Education: Associates degree plus two years related work experience OR an equivalent combination of relevant post secondary education and work experience that equals at least 4 years.

Work Experience:

• Experience using the Microsoft Office Suite.

• Two 2 years of relevant work experience.

• Experience working with patients families physicians and administrative staff.

Preferred Qualifications

Education/Certifications:

• Bachelors degree in relevant field under preferred education.

• SOCRA CCRP certification

Work Experience:

• Prior health care and/or research experience.

• Experience with electronic medical records.

• Experience in Neurology and/or Neuromuscular research.

Skills

• Attention to detail

• Timemanagement skills.

• Interpersonal skills.

• Multitasking skills.

Required Documents

• Resume/CV

• Cover Letter

Comprehensive Benefits Package: