Clinical Research Coordinator

Competition 2395

This position is a part of the Non-Academic Staff Association (NASA).

This position has a term length of 1 year plus 1 day and offers a comprehensive benefits package.

This competition will be used to hire for 2 positions.

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

Working at the University of Alberta

The University of Alberta acknowledges that we are located on Treaty 6 territory, and respects the histories, languages and cultures of First Nations, Métis, Inuit and all FirstPeoples of Canada, whose presence continues to enrich our vibrant community.

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 than 40,000 students and a growing community of 300,000 alumni worldwide.

Your work will have a meaningful influence on a fascinating cross-section of people — from our students and community members, to our renowned researchers and innovators, making discoveries and generating solutions that make the world healthier, safer, stronger and more just. Learn more.

Working for the Department of Surgery

The Department of Surgery has 15 divisions and offers programs in undergraduate, graduate and postgraduate studies.  The department also includes many other research groups who contribute to cutting edge advancement in areas such as transplantation, joint preservation and regeneration and surgical simulation technology.  Founded in 1922, the department has been a leader in its field, striving to achieve a balance between technology and the human element that defines the art of surgery.  The overarching mission of the department is to restore health through surgical intervention, and to remember that patient dignity and comfort are integral to overall health.  Further information on the department can be found at www.ualberta/ca/surgery.

Position Summary

The Alberta Center for Urological Research and Excellence (ACURE) is recruiting for two Clinical Research Coordinators (CRCs). As an integral member of the ACURE research team, the Clinical Research Coordinators work in a dynamic, collaborative, quality-focused environment. Research staff interacts with technical, medical and management staff at the Kipnes Urology Centre, in addition to partnering hospitals and clinical trial regulatory bodies. The role of the CRCs provide an interesting and challenging opportunity to collaborate with Investigators and the health care team to assume responsibility for the overall patient enrollment and coordination of clinical studies or the ACURE research projects including recruitment to Alberta Prostate Registry and BioRepository as well as Investigator- and Industry- initiated trials. 

Duties 

• 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.
• 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.
• 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.

Minimum Qualifications

• BSc. or BScN. Combination of education and experience will be taken into consideration.
• Previous clinical research experience.
• Certification in Phlebotomy mandatory.
• Proficiency with MS Office Software -Word and Excel required.

Preferred Qualifications 

• Knowledge of IATA shipping regulations and basic laboratory procedures an asset.
• Recognized certification in clinical research (ACRP or SOCRA) obtained or in the works an asset.
• Training in ICH/GCP guidelines and GCP Certificate an asset.
• NACTRC research course an asset