The primary responsibility of the clinical research coordinator is to manage all aspects of conducting clinical trials. The clinical research coordinator is required to have an in-depth knowledge of protocol requirements and good clinical practices as set forth by federal regulations. As the primary resource for the protocols, the clinical research coordinator will act as liaison between the Director of Bariatric Services, investigators, primary care providers, the institutional review board (IRB), and the sponsor. Along with the investigator, the clinical research coordinator will screen, enroll and follow study subjects; ensuring protocol compliance and close monitoring while the subjects are on study. In addition, the clinical research coordinator is responsible for data and source documentation, adverse experience reporting and maintenance of regulatory files.
Possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility.
Review the study design and inclusion/exclusion criteria with the subject’s primary physician, if necessary.
Review, verify, and update all relevant source documentation in the subject’s medical record to confirm study eligibility.
Review the protocol, informed consent form, and follow-up procedures with potential study subjects.
Ensure the current approved informed consent is signed before subjects are screened and enrolled.
Ensure that the randomization procedure is followed as per protocol guidelines.
Document protocol exemptions and deviations, as appropriate.
Data management/CRF completion
Adverse event reports
Develop organizational tools
Storing, dispensing, accounting for study drug/device
Monitoring patient compliance
Subject enrollment and follow-up
Clinical testing, assessments and physical examinations as delegated
Adverse event determination
Communicate regularly with the principal investigator and director about study-related issues.
Maintains confidentiality of all materials handled within the Network/ Entity as well as the proper release of information.
Complies with Network and departmental policies regarding issues of employee, patient and environmental safety and follows appropriate reporting requirements.
Demonstrates/models the Network’s Service Excellence Standards of Performance in interactions with all customers (internal and external).
Demonstrates Performance Improvement in the following areas as appropriate: Clinical Care/Outcomes, Customer/Service Improvement, Operational System/Process, and Safety.
Complies with Network and departmental policies regarding attendance and dress code. During direct patient care must wear appropriate St. Luke’s lab coat or uniform.
Demonstrates competency in the assessment, range of treatment, knowledge of growth and development and communication appropriate to the age of the patient treated.
PHYSICIAL AND SENSORY REQUIREMENTS:
Requires full range of body motion, including handling and lifting patients, manual and finger dexterity with eye-hand coordination. Requires standing, walking and sitting for extensive periods of time. Occasionally lifts and caries items weighing up to 50 pounds or more. Requires corrected vision and hearing to normal range.
POTENTIAL ON-THE-JOB RISKS:
Frequent exposure to communicable diseases and bodily fluids, medical preparations, procedures and other conditions common to a practice environment. Requires performing assigned duties without placing self and other at undue risk. Potential exposure to patients with suspected or proven tuberculosis (TB) must have the ability to wear a particulate respirator and be fit-tested in compliance with the current recommendations from the CDC (enforced by OSHA) or must provide physician documentation as to the inability to wear a particulate respirator. Universal precautions must be maintained at all times.
MOST COMPLEX DUTY:
Balancing and understanding multiple protocols with different responsibilities.
SUPERVISION (RECEIVED BY AND/OR GIVEN TO):
Director of Bariatric Services
As needed with director.
Nursing degree, including LPN, RN or BSN.
TRAINING AND EXPERIENCE:
Minimum of one year of clinical nursing; one year of clinical research preferred but not required.