Clinical Research Coordinator

Job Description

This competition is open to all applicants however; internal candidates and applicants who were former employees of the University of Alberta will be given priority consideration before external candidates. Please log in to verify your internal candidate status. This position has a term length of 1 year plus 1 day.

Location

This role is in-person at North Campus Edmonton.

Responsibilities

Administrative Roles 50%:

• Plans and coordinates the initiation of research study protocols.
• Participates in protocol management, reviews and adheres to multiple research protocols.
• Reconciles research accounts, assists with accounts and prepares invoices for payment.
• Assembles study-specific source documents and prepares study binders to ensure regulatory documentation is maintained to meet the study requirements.
• Contributes to the development and maintenance of protocols, ethics applications, manuals, guidelines, SOPs, intake surveys, QoL questionnaires, and other study-associated documents.
• Provides ongoing written and oral reporting with the University Health Ethics Research Office (ARISE), Northern Alberta Clinical Trials and Research Centre (NACTRC), Human Research Ethics Board of Alberta (HREBA), investigators and industry sponsors.
• Works with investigators to notify departments of the study termination/compliance and ensures appropriate retention of study files/materials.
• Conducts daily aspects of trials according to defined study protocols.
• Monitors the progress of research activities, develops and maintains records of research activities, and prepares periodic and ad-hoc reports, as needed.
• Develops and implements quality control processes throughout the study.
• Establishes, executes, reviews and evaluates laboratory policies and procedures for operating functions, including manuals and SOPs, as well as manages all laboratory department’s activities.
• Provides access to laboratory personnel for consultation and determines operational troubles in timely manner.
• Monitors, orders and receives all study, lab and drug supplies, performs drug accountability and monitors expiry dates for all supplies.
• Performs quality assurance of medical lab equipment; orders, maintains and calibrates yearly.
• Maintains and updates WHMIS documentation and all other laboratory records, reports and files.
• Organizes the research lab to accommodate ongoing requirements and changing goals of the research department.
• Other miscellaneous tasks, such as supporting other programs, as assigned.

Patient Facing Activities 50%:

• Provides instruction/teaching to study participants regarding participation, protocol requirements, follow-up schedule, and the use of data collection tools.
• Conducts patient recruitment, follow-up, data collection, case report form (CRF) completion, study monitoring, data query resolution, promotes patient’s adherence to the study and monitors patient safety in relation to the study protocols. Performs venipuncture to obtain blood samples, instructs patients to obtain urine or semen samples, requests, processes, stores tissue samples according to protocols and SOPs, and transfers samples to long-term storage facilities in a regular manner.
• Transfer samples to long-term storage facilities according to established SOPs.
• Instructs/collects/handles/transports urine, stone, implanted devices (catheters, stents etc.) from patients.

Qualifications

• BSc. or BScN. A combination of education and experience will be considered.
• Recognized certification in clinical research (ACRP or SOCRA) obtained or in progress is an asset.
• Previous clinical research experience
• Training in ICH/GCP guidelines and GCP Certificate an asset.
• Certification in Phlebotomy mandatory.
• NACTRC research course an asset.
• Proficiency with MS Office Software - Word and Excel required.
• Knowledge of IATA shipping regulations and basic laboratory procedures an asset.

About Us

The University of Alberta, its buildings, labs and research stations are primarily located on the territory of Néhiyaw (Cree), Niitsitapi (Blackfoot), Métis, Nakoda (Stoney), Dene, Haudenosaunee (Iroquois) and Anishinaabe (Ojibway/Saulteaux), lands that are now known as part of Treaties 6, 7 and 8 and homeland of the Métis. The University of Alberta respects the sovereignty, lands, histories, languages, knowledge systems and cultures of all First Nations, Métis, and Inuit.

The University of Alberta is a community of knowledge seekers, change makers and world shapers who lead with purpose each and every day. We are home to over 14,000 faculty and staff, more th