Description:
Summary of Key Responsibilities (job functions include but are not limited to):
Patient Management
- Reviews referrals and medical histories. Determines eligibility and suitability for protocol based on presenting and interview assessment information. In consultation with the Principal Investigator and clinical care team, the RC also determines where to forward the referral should the patient not be suitable.
- Follows GCP, ICH guidelines and Hepatology clinic SOPs during the informed consent process.
- Completes screening utilizing appropriate tools and clinic pathway/thresholds; utilizes an advanced knowledge and skill in history and physical assessment.
- Responsible for patient contact and scheduling, as well as room and procedure bookings
- When eligibility is confirmed:
- Assess the needs of the patient to promote consistency and quality of care
- Determine a plan of care based on the assessment and protocol compliance
- Prepares the patient physically and emotionally for protocol participation requirements, assess need for referrals to an interdisciplinary care team
- Implement protocol required activities ensuring excellence in delivery of the research process
- Evaluates/monitors patients' response, recommends changes as needed
- Provides education and nursing support as determined by study participant and family assessment.
- Liaise with various health care providers in disseminating results of research findings
Administration
- Have an extensive knowledge of ongoing research projects
- Prepare subject research charts including source documentation of patient files; certified copies of the original and medical histories
- Maintaining accurate and detailed records of patient files to ensure they fit all criteria to be enrolled in specific clinical trials
- Ensure data entry is accurate and precise and is entered in a timely manner according to research protocols
- Aide in the preparation and submission of regulatory documentation
- Aide in ethics submissions, revisions, and annual approvals process
- Amend study protocols and consents as required¿
Monitoring Support
- Manage all aspects of sponsor monitoring visits:
- Scheduling and room bookings
- Preparing and filing study documentation prior to visit
- Ensuring the monitor has everything required for the visit
- Constant communication with monitor and coordinator to ensure an effective visit
- Obtaining proper documentation before during and after visit, as required
- Communicate with sponsor and affiliates regarding study progress
- Facilitate regulatory document completion and updates as necessary
- Ongoing maintenance of study binders