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. This position ensures that study procedures follow the sponsor's protocol and all applicable regulatory requirements while prioritizing the well-being and safety of research participants and their families.

Responsibilities

• Recruits, evaluates, and educates patients regarding clinical trials related to neuromuscular disease.
• Conducts Informed Consent Interviews with participants and caregivers following Neuromuscular Program Standard Operating Procedures (SOP) for cognitively normal and cognitively impaired individuals, including determination of when a Surrogate consent form is necessary.
• Documents trial-related activities per regulatory requirements in a timely and accurate manner.
• Coordinates all aspects of study visit activities, including scheduling hospital-based procedures such as MRI, PET, ECG, lab draws, IV infusions, lumbar punctures, and dispensation of study medication.
• Gathers accurate medical history and concomitant medication information to ensure compliance with trial specifications.
• Monitors patients and caregivers for changes in health or potential adverse events, prepares formal reports for sponsors and IRB as needed, and submits Serious Adverse Event (SAE) reports to regulatory authorities within 24 hours.
• Assists physicians in cerebrospinal fluid (CSF) collection, including patient education, supply preparation, maintaining sterile fields, aliquoting CSF, and post-procedure follow-up.
• Prepares and ships biological specimens to central labs per protocol and regulatory requirements.
• Conducts interviews with patients and/or caregivers regarding mood, anxiety, neurobehavioral symptoms, and functional abilities.
• Ensures all study staff complete required training for proper trial conduct.
• Facilitates timely review of lab tests, imaging results, and communicates clinically relevant information to patients and their primary care doctors.
• Maintains regulatory binders, updates subject records, and ensures availability of medical records and protocols.
• Prepares adverse event and protocol deviation reports for IRB submissions.
• Assists in preparation of IRB submissions, including consent forms, new study and continuing review applications, and protocol amendments.
• Ensures all study data is entered into sponsor-provided or internal databases within 3 business days of collection.
• Occasionally travels to attend national meetings.

Requirements

• 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.

Qualifications

• Preferred Education: Bachelor's degree in basic science or health-related field.
• Preferred Certifications/Licenses: SOCRA CCRP certification.
• Preferred Work Experience:
  • Prior healthcare or research experience.
  • Experience with electronic medical records.
  • Experience in Neurology or Neuromuscular research.
• Skills:
  • Attention to detail
  • Time management
  • Interpersonal skills
  • Multitasking
  • Computer skills

Benefits

• Coverage begins on day one for health, dental, and vision insurance, including health expense accounts with generous employer contributions.
• Employer-paid life insurance and long-term disability insurance.
• Various additional voluntary insurance plans available.
• Paid time off, including vacation and sick leave, accruing upon hire, plus ten paid holidays.
• One paid discretionary day after six months of employment.
• Paid time off for bereavement, jury duty, military service, and parental leave after 12 months of employment.
• Retirement program with generous employer contribution and additional voluntary retirement programs (457 or 403b).

For more details, visit KU Medical Center Benefits.

Pay

The pay range for this position is $60,800.00 - $91,200.00, with a starting pay range typically between the minimum ($60,800.00) and midpoint ($76,000.00) based on education, experience, qualifications, and funding.

Schedule

• Employee Type: Regular
• Time Type: Full time
• Rate Type: Salary