Clinical Trial Research Coordinator

This position has a term length of 1 year plus 1 day, with the possibility of extension.

Location - This role is in-person at North Campus Edmonton.

The Division of Gastroenterology is seeking a licensed practical nurse with clinical research experience to coordinate patient-facing clinical trials under the supervision of Dr. Frank Hoentjen. In this role, you will guide participants through the full trial journey - from screening and informed consent to study visits, investigational product administration, safety follow-up and study close-out activities.

You will combine direct participant care with precise documentation, data entry and regulatory coordination. Working closely with investigators, clinical teams, contract research organizations and study sponsors, you will help ensure that trials are conducted safely, ethically and in accordance with approved protocols.

Trials will mainly focus on liver disease and inflammatory bowel disease.
 

Participant recruitment and study visits

• Identify and pre-screen potential participants by reviewing clinical databases, previous study records, clinic charts and new patient referrals.

• Recruit eligible participants, explain study requirements, obtain and document informed consent, and provide participants with the required records.

• Coordinate and conduct study visits, monitor participant adherence, provide condition- and therapy-related education, and serve as a key link between participants and investigators.

• Arrange and, when required, attend trial-related procedures such as endoscopy, imaging, FibroScan, pulmonary function testing, infusion visits and liver biopsy.

Clinical trial delivery and participant safety

• Complete protocol-specific clinical activities, which may include electrocardiograms, physical assessments and endoscopic recordings, following required training and authorization.

• Dispense and administer investigational products, maintain accountability and appropriate on-site storage, and coordinate with the research pharmacy and Clinical Investigation Unit.

• Identify, document, report and follow up on adverse events, serious adverse events and events of special interest within protocol timelines.

• Communicate relevant safety updates to participants and seek protocol clarification from trial medical monitors at the investigator's direction.

Documentation and data quality

• Create, review and maintain accurate source documentation, electronic case report forms, study flow sheets and electronic medical record entries.

• Collect, enter and verify trial data; resolve clarification requests and data queries promptly and accurately.

• Perform quality assurance activities to support consistent, protocol-compliant data and prepare study records for monitoring visits and audits.

• Maintain source files and investigational product records in accordance with trial, sponsor and regulatory requirements.

Study coordination and team support

• Coordinate with investigators, gastroenterologists, clinical services, contract research organizations, sponsors and external vendors to keep trial activities on track.

• Order, track and appropriately dispose of trial supplies, including study drugs, central laboratory materials, electronic diaries and general project supplies.

• Update standard operating procedures and train newly hired research coordinators on study processes and expectations.

• Licensed Practical Nurse designation.

• 3+ years of clinical research experience, with an emphasis on gastroenterology.

• Experience working directly with patients, recruiting participants to clinical trials and administering investigational products.

• Experience with clinical research data management and regulatory processes.

• Excellent organizational, analytical and time-management skills, with the ability to manage multiple concurrent priorities and timelines.

• Excellent written and verbal communication skills in English.

• Demonstrated accuracy, sound judgment and commitment to professional and ethical practice.

• Ability to work independently and collaboratively as part of a research and clinical care team.

• Flexibility to adjust working hours when required by study activities.

Application Instructions

Click "Apply Now" to submit your resume and cover letter.

This position is subject to all applicable terms and conditions of the collective agreement between the Governors of the University of Alberta and the Non-Academic Staff Association (NASA).

This position offers a comprehensive benefits package.