Clinical Research Coordinator - Neurology (Neuromuscular)

About the role

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.

Responsibilities

• 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.
• Captures and 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 like 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.
• Aids 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.
• Aids in ensuring all study staff complete required training for proper conduct of the trial.
• Aids in ensuring 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.
• Aids in updating and maintaining regulatory binders.
• Aids in preparing adverse event reports and protocol deviation reports for submission to IRB.
• Aids 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.
• Aids in ensuring all study data is entered into sponsor-provided and/or internal KU databases per sponsor requirements, typically within 3 business days following data collection.

Qualifications

• 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.
• Bachelor's degree in basic science or health related field.
• SOCRA CCRP certification.
• Prior health care or research experience.
• Experience with electronic medical records.
• Experience in Neurology or Neuromuscular research.
• Attention to detail.
• Time-management.
• Interpersonal skills.
• Multitasking.
• Computer skills.