Clinical Research Coordinator, Department of Medicine

Description

The Department of Medicine in the Cumming School of Medicine invites applications for a Clinical Research Coordinator. This Full-time Fixed Term position is for approximately 12 months (based on length of grant funding), with the possibility of extension.

Reporting to the Principal Investigator.

The team is engaged in clinical trial and health service research in all areas of kidney and chronic disease management, evaluation, interventional, observational, & qualitative clinical studies. This includes studies in Phases 2, 3, 4, pragmatic, Industry Sponsored, and Investigator Initiated studies of drug/device safety and efficacy and care interventions.

Summary of Key Responsibilities (job functions include but are not limited to):

Clinical Research Coordination

• Responsible for delegated tasks related to research protocols (review, feasibility), ethics submissions (including but not limited to - applications, modifications, renewals, deviations, closures) and all research contract and vendor agreements

• Responsible for the successful coordination work of one or more simultaneous studies in accordance with protocols, applicable contracts, budget requirements, and in compliance with all policies, procedures, and guidelines of the research group, the University of Calgary, applicable regulatory bodies, and the research ethics board

• Evaluating and revising recruitment plans; completing ethics applications; study contract process functions; assisting with vendor contracts and maintaining electronic data base platform

• Assists in performing feasibility assessments of patient population and helps to analyze specific study protocol inclusion / exclusion criteria against standards of care at the site

• Assists with the development and revisions in the application and maintenance of study specific standard operating procedures (SOP's) and procedures related to research activities for each of the projects delegated to them

• Coordinates and cooperates with the University of Calgary, Cumming School of Medicine, and external entities (i.e. Health Canada, FDA, Industry Sponsors) in compliance and monitoring efforts related to clinical trials

• Attends investigator meetings as required or requested by PI

• Prepares study files as delegated by the PI. These study materials include but are not limited to regulatory binders, informed consent documents, case report forms (CRF's), enrollment logs, drug/devise accountability logs, and study specific source documents

• Assists in the registration (if required) of the study (i.e., ClinicalTrials.gov) and maintains current information on the site

• Arranges the secure storage of all study documents that will be maintained according to University of Calgary policy, Health Canada, FDA or for the Sponsor contracted length of time

Communication / Interaction / Compliance monitoring

• Communicates and works with internal and external research parties, along with the PI

• Ensure their projects and research activities adhere to ethical guidelines and legal requirements for research

• Implements clinical study protocols, monitor daily study activity, and prepare reports to PI as appropriate

Qualifications / Requirements:

• RN, BScN active designation or Masters degree in relative area required. PhD degree in relevant field is an asset
• Must have experience in clinical trial research and have a satisfactory understanding of health care delivery in both community and acute care settings
• Certified Clinical Research Professional (CCRP) designation preferred
• Minimum of 5 years of relevant work experience in clinical research in an academic setting including significant experience in the startup and management of clinical research trials
• Experience in nephrology related care would be considered an asset
• Phlebotomy Certificate an asset
• Experience in performing Electrocardiograms an asset
• SPOR Pragmatic Clinical Trials certificate is an asset
• Proven experience working with/on research protocols, ethics submissions, research agreements/contracts, financial reporting, project progress reporting, and scientific writing skills preferred
• Experience in working in an academic health research setting with researchers, practitioners and patient groups is an asset
• Demonstrated flexibility with work hours and assisting the research team to meet priorities/deadlines
• Working knowledge and experience with ICH-GCP requirements, HIA, PIPA, FOIP, TCPS2, HC Div5, and FDA regulations preferred
• Must be proficient in standard system software applications (e.g. MS Word, Excel, Outlook, PowerPoint and the Internet)
• Experience with University of Calgary financial, human resource and supply chain management systems and procedures considered an asset
• Project management and/or research certifications (e.g. CCRP) are considered assets
• Familiarity with knowledge translation and qualitative research methods (including patient focus groups and surveys [i.e. Fluid Surveys, Simple Survey]) are assets
• An understanding of knowledge translation is an asset

Application Deadline: April 26, 2024

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.

This position is part of the AUPE bargaining unit, and falls under the Technical Job Family, Phase 2.

For a listing of all management and staff opportunities at the University of Calgary, view our Management and Staff Careers website.

About the University of Calgary

UCalgary is Canada's entrepreneurial university, located in Canada's most enterprising city. It is a top research university and one of the highest-ranked universities of its age. Founded in 1966, its 36,000 students experience an innovative learning environment, made rich by research, hands-on experiences and entrepreneurial thinking. It is Canada's leader in the creation of start-ups. Start something today at the University of Calgary. For more information, visit ucalgary.ca.

The University of Calgary has launched an institution-wide Indigenous Strategy 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 (equity@ucalgary.ca) and requests for accommodations can be sent to Human Resources (hrhire@ucalgary.ca).

Do you have most but not all the qualifications? Research show that women, racialized and visible minorities, and persons with disabilities are less likely to apply for jobs unless they meet every single qualification. At UCalgary we are committed to achieving equitable, diverse, inclusive and accessible employment practices and workplaces and encourage you to apply if you believe you are right for this role.

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