The Department of Medicine in the Cumming School of Medicine invites applications for a Research Coordinator. This Fixed Term Full-time position is for approximately 12 months (based on length of grant funding), with the possibility of extension. The Research Coordinator (RC) reports to the Principal Investigator of the Inflammatory Bowel Disease Unit.
The research coordinator is a health care professional who functions as an administrator, coordinator, consultant, educator, and researcher in the organization of investigator initiated and pharmaceutical sponsored clinical trials as well as the PI initiated research projects. The RCs main task will be to coordinate prescreening processes within the IBD Unit to ensure patients are identified as possibly eligible for ongoing clinical trials.
They will also be involved with clinical trials and investigator initiated trials as the main coordinator who facilitates recruitment and retention of trial subjects. The role will also assist in monitoring clinical trials to ensure compliance of procedures and protocols.
Key Responsibilities 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.
- 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.
- Prepare reportable event submissions.
- Responsible for room and procedure bookings.
- Organize and develop patient kits for various studies.
- 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.
- Provides research related information to support staff ensuring high…
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