Company Information
Liver Institute PLLC is a specialist (hepatology) practice designed to offer a comprehensive, multidisciplinary approach to the diagnosis and management of Liver Disease. Liver Institute PLLC approaches liver disease through a three-pillar approach: treatment, education, and research.
Qualifications
Bachelors degree Required
Minimum of one year experience as a clinical research coordinator or two years healthcare experience with patient interaction or related experience
Experience with regulations governing clinical research (CFR, GCP, HIPAA)
Experience with statutes and guidelines relevant to regulatory affairs in clinical research
Excellent communication as evidenced in application materials
Excellent writing, organizational and presentation skills
Effectively interact with multidisciplinary teams including physicians, administrative staff
Experience recognizing competing priorities and deadlines and seek guidance in management of these where needed
Willingness to seek research certifications to further skills in the position
Responsibilities
This position is responsible for working collaboratively with multidisciplinary teams, research and clinical staff to 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, evaluation, and education of patients for clinical trials; documentation per regulatory requirements; and work with research team for protocol management
Conducts Informed Consent Interview with participant and caregiver following Standard Operating Procedures (SOP) for obtaining consent
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 according to protocol requirements
Maintain trial regulatory documentation including correspondence with sponsor, 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 the 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 the principal investigator’s determination of adverse event (AE) qualification, prepares formal AE report for a sponsor, when applicable per regulations
Assists physicians in procedures for clinical trials by educating patient/caregiver regarding the study procedure
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 the protocol and regulatory requirements
Conducts interviews with patient and/or caregiver as directed in protocol.
other duties may be assigned by PI as needed.
Pay: From $16.00 per hour
Medical Specialty:
Education:
Experience:
- Clinical Research Associates & Coordinators: 1 year (Preferred)
Work Location: In person
