Position Overview

The Department of Medicine in the Cumming School of Medicine invites applications for a Research Coordinator. This Full-time Fixed Term position is for approximately 1 year (based on length of grant funding), with the possibility of extension.

The Research Coordinator (RC) reports to the Clinical Research Manager, Calgary Liver Unit.

This is a dynamic position that works within the framework of the University and the Cumming School of Medicine Policies and Procedures, as well as within the Hepatology specific Clinical Research Standard Operating Procedures (SOPs). 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 University of Calgary Liver Unit Health Information and Biorepository (UCLU HIB). The RCs main task will be to coordinate pre screening processes within the Liver 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.

Occasional travel may be required.

Position 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

Communication/Relationships 

• Provides research related information to support staff ensuring high quality care is delivered by the team of providers
• Maintain ongoing communication with the collaborative team.
• Good relationships are developed and maintained with various stakeholders.
• Takes a leadership role in maintaining various research projects by communicating with allied health professionals and staff, ensuring that protocols are followed
• Good relationships are developed and maintained with University of Calgary and Alberta Health Services staff within the liver unit and GI clinic

Qualifications / Requirements:

• Undergraduate degree in life sciences, or equivalent required
• Graduate of approved school of nursing or Bachelor of Nursing, or LPN an asset
• Should successful candidate not possess RN/LPN degree, some tasks may be supervised as appropriate by licensed RN/LPN
• Certified Clinical Research Professional (CCRP) designation from the Society of Clinical Research Professionals (SoCRA) an asset
• At least two years’ experience in a clinical research coordinator position using clinical research methodologies preferred
• Recent experience in industry-sponsored and/or investigator-initiated clinical research studies involving pharmaceutical intervention and direct participant interaction preferred
• Experience in Hepatology considered an asset
• Strong working knowledge of Microsoft Office applications (Outlook, Word, Excel, Access & Powerpoint)
• Strong attention to detail required
• Current First Aid/CPR an asset
• Biohazard certification an asset
• WHIMIS certification an asset
• Certification in IATA, knowledge of the transportation of Dangerous Goods an asset
• Phlebotomy training, or willingness to train an asset
• Knowledge of internal review boards, sponsor operations and legal obligations for research projects as well as the International Conference on Harmonization (ICH), Declaration of Helsinki guidelines and the Tri-council Policy Statement an asset
• Basic statistical knowledge an asset
• Demonstrated technical dexterity, knowledge, organizational, interpersonal, administrative skills and skills working with computer technology - required
• Demonstrated ability to function independently and within a team environment - required
• Strong leadership, communication and decision making skills - required
• Demonstrated superior clinical physical and emotional assessment skills – required
• Continue Hepatology/Nursing education by attending yearly Hepatology courses, conferences, seminars and presentations offered (can be evening and weekend)

Application Deadline:  June 14, 2023

We would like to thank all applicants in advance for submitting their resumes. Please note, only those candidates chosen to continue on through the selection process will be contacted.

Additional Information

This position is part of the AUPE bargaining unit, and falls under the Technical Job Family, Phase II.

To find out more about management and staff opportunities at the University of Calgary and all we have to offer, view our Management and Staff Careers website. For more information visit Careers in the Cumming School of Medicine.

The University strongly recommends all faculty and staff are fully vaccinated against COVID-19.

About the University of Calgary

The University of Calgary is Canada’s leading next-generation university – a living, growing and youthful institution that embraces change and opportunity with a can-do attitude. Located in the nation’s most enterprising city, the university is making tremendous progress on its Eyes High journey to be recognized as one of Canada’s top five research universities, grounded in innovative learning and teaching and fully integrated with the community it both serves and leads. The University of Calgary inspires and supports discovery, creativity and innovation across all disciplines. For more information, visit ucalgary.ca.

The University of Calgary has launched an institution-wide Indigenous Strategy in line with the foundational goals of Eyes High, committing to creating a rich, vibrant, and culturally competent campus that welcomes and supports Indigenous Peoples, encourages Indigenous community partnerships, is inclusive of Indigenous perspectives in all that we do.

As an equitable and inclusive employer, the University of Calgary recognizes that a diverse staff/faculty benefits and enriches the work, learning and research experiences of the entire campus and greater community. We are committed to removing barriers that have been historically encountered by some people in our society. We strive to recruit individuals who will further enhance our diversity and will support their academic and professional success while they are here. In particular, we encourage members of the designated groups (women, Indigenous peoples, persons with disabilities, members of visible/racialized minorities, and diverse sexual orientation and gender identities) to apply. To ensure a fair and equitable assessment, we offer accommodation at any stage during the recruitment process to applicants with disabilities. Questions regarding [diversity] EDI at UCalgary can be sent to the Office of Equity, Diversity and Inclusion ([email protected]) and requests for accommodations can be sent to Human Resources ([email protected]).

We encourage all qualified applicants to apply, however preference will be given to Canadian citizens and permanent residents of Canada.