- Six months experience in clinical research, or equivalent.
- Experience in regulatory, FDA codes and guidelines for Good Clinical Practices.
- Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA)
- Basic understanding of statutes and guidelines relevant to regulatory affairs in clinical research.
- Knowledgeable of study budgets, contracts, and grant applications.
- Excellent communication skill, organizational and presentation skills;
- Ability to interact with multidisciplinary teams including, physicians, administrative staff
- Excellent time-management skills.
- Recruitment, evaluation and education of patients for clinical trials; documentation per regulatory requirements; and work with research team for protocol management.
- Recruits, evaluates, and educates patients regarding clinical trials related to Epilepsy.
- Conducts Informed Consent Interview with participant and caregiver following epilepsy 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.
- Maintain trial regulatory documentation including correspondence with sponsor, KUMC Human Subject Committee and subjects.
- 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.
- Other duties as assigned.
- Resume/CV
- Cover Letter
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Clinical Research Coordinator - Kansas City, United States - University of Kansas Medical Center
Description
Department:
SOM KC Neurology - Epilepsy
* -Epilepsy
Position Title:
Clinical Research Coordinator - Neurology
Job Family Group:
Professional Staff
Job Description Summary:
This position is responsible for working collaboratively with multidisciplinary teams, research and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of clinical research.
The Clinical Research Coordinator will manage clinical research studies by coordinating and participating in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data.
Monitor participants' progress including documenting and reporting adverse events. Participate in periodic quality assurance audits of protocols.Job Description:
Required Qualifications
Education:
Associate's 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:
Education:
Bachelors' 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 in Neurology, Epilepsy Patient.
Skills:
Job Duties Outlined:
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.
Required Documents:
Comprehensive Benefits Package:
Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan.
One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment.
A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available.Employee Type:
Regular
Time Type:
Full time
Rate Type:
Salary
Compensation Statement:
The pay range listed for this position is determined by our compensation program using market data and salary benchmarking.
A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding.
At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above.
Pay Range:
$58, $86,000.00
Minimum
$58,000.00
Midpoint
$72,000.00
Maximum
$86,000.00
