Interior Health is looking for a casual Coordinator, Clinical Research to join our dynamic team at the Kelowna General Hospital!
About the Role :
The Coordinator, Clinical Research is a specialized research professional that works under the oversight of the Principal Investigator (PI) within individual studies and reports to the Manager, Clinical Research.
The Coordinator performs multiple functions in a complex and dynamic work environment including acting as the primary administrative point of contact for internal research staff and the operational liaison for other research organizations, funding agencies, and regulating bodies.
The Coordinator has a key role in developing the plan for new clinical trials in terms of determining budget and operational planning (e.
g., liaison with IH clinical department staff, space requirements, and physicians). The Coordinator supports, facilitates, and organizes daily clinical trial and study participant activities and plays a critical role in study conduct.
The Coordinator screens, enrolls, and follows study subjects, ensuring protocol compliance and close monitoring while the subjects are on study.
In addition, the Coordinator is responsible for ensuring that data is submitted on a timely basis; source documentation is accurate and complete;
and all ethical and regulatory requirements are met. Data management responsibilities include : the collection, analysis, confidentiality, and quality assurance review of study participant clinical and research data.
By performing these duties, the Coordinator works with the PI and study team / vendors to ensure the successful conduct of regulatory-compliant and ethically sound studies.
Some Key Duties may include :
Conducts all study-related activities in accordance with the study protocol and Sponsor’s instructions, institutional policy and standard operating procedures, Good Clinical Practice (GCP standards), ethical requirements, and applicable national and international regulations.
Participates in the clinical trial protocol and the grant, contract, and budget development and review process.
Participates in the protocol and site feasibility assessment process.
Implements the research protocol and all required procedures within the scope of qualifications and under the delegation of the PI.
Diligently consults with Research Nurses on data, protocol, or patient assessment issues.
Establishes a strong, positive, and supportive relationship with each participant, fostering compliance to protocol requirements and trust.
Acknowledges the importance of each participant’s role as a research volunteer.
Ensures that the rights, safety, and welfare of all participants are respected and protected as per applicable ethical requirements, GCP, and regulations.
Either oversees or participates directly in timely (real time) study data collection, query resolution, analysis, and quality assurance throughout the trial.
Ensures that essential documents are archived following study completion.
Performs data management activities on both paper-based and electronic data capture (EDC) studies, in accordance with Good Data Management Practices (attributable, legible, contemporaneous, original, and accurate ALCOA), Good Clinical Practice (GCP standards, IH research policies and procedures, and applicable research and privacy legislation).
Prepares source document forms specific to study protocols and Case Report Forms (CRFs), when needed for Investigator-initiated studies, in collaboration with the study team.
Reviews CRF data for accuracy and completeness, enters data in accordance with study specific requirements, responds to and resolves queries in accordance with protocol and / or contractual time specifications, manages discrepancies, and addresses any ad-hoc reporting requirements as per each study’s needs.
Coordinates data flow internally and externally and collects data from all sources (electronic and paper) including, but not limited to, the electronic health record, other databases, and paper medical records / charts.
Assists Principal Investigators and study staff in the creation of data reports for quality assurance purposes.
Ensures ongoing and precisely documented communication with Sponsors, Monitors, and regulatory bodies, as required, for a broad range of study activities including, but not limited to, safety reporting.
Develops protocol-specific case report forms, informed consent documents, and source document tools.
Educates other healthcare professionals, the community, potential study participants, and their families about clinical trials.
Promotes research capacity-building among IH and community-based organizations.
Maintains investigational drug / device accountability records and ensures the investigational products are stored and accessed in accordance with Sponsor instruction.
Performs other related duties as assigned.
Make a difference. Love your work. Apply today! Interior Health strives to create an environment where you enjoy the work you do, the place where you work, and the people around you.
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Education, Training, and Experience :
A level of education, training, and experience equivalent to a Master’s degree in a health research, healthcare, or clinical research discipline or equivalent experience.
A minimum of five years of practical clinical research work experience at a research site. Other clinical research environments will be considered.
A minimum of five years of practical clinical research work experience at a research site may be considered in lieu of education.
Certification through the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA) as a Certified Clinical Research Coordinator (CCRC), a Certified Clinical Research Associate (CCRA), or a Certified Clinical Research Professional (CCRP) is strongly preferred.
Certification is required within two years of hire date.
Completion of Tri-Council Policy Statement 2 : Ethical Conduct for Research Involving Humans and GCP requirements for protection of the rights of study participants training.
Demonstrates all LEADS Capabilities, in particular :
Leads Self self-awareness, demonstrates character
Engages Others communicates effectively
Achieves Results takes action to implement decisions, assesses & evaluates results
Develops Coalitions mobilizes knowledge, demonstrates a commitment to customers & service
System Transformation encourages and supports innovation, champions & orchestrates change
Skills and Abilities
In-depth knowledge of Health Canada Food and Drug Act, Division 5, Part C; International Committee on Harmonization Part E6 Good Clinical Practices;
and US Food and Drug Act regulations 21 CFR and 45 CFR part 46 pertaining to clinical trials.
Functional understanding of the Freedom of Information and Privacy Act (FIPPA), in particular section 35.
Excellent interpersonal skills, advanced written and verbal communication, pro-active problem-solving abilities, and a well-demonstrated ability to work with others as part of an interdisciplinary team.
Exceptional attention to detail and an advanced ability to organize information and multi-task / prioritize in a busy environment.
Highly proficient with databases, MS Office (particularly Word, Excel, and PowerPoint), email, and the internet.
Experience with Remote Data Capture (RDC) and Electronic Data Capture (EDC) systems.
Physical ability to perform the duties of the position.