COORDINATOR, CLINICAL RESEARCHApply Now Job ID 1262499 Date posted 05/17/2019
Facility :KELOWNA GENERAL HOSPITAL
Interior Health is seeking a Coordinator, Clinical Research for a casual position in Kelowna, BC!
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.
• 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. Competencies
• 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.
Interior Health values diversity and inclusion. Our goal is to cultivate a workforce rich in culture, experience and knowledge to ensure equitable health outcomes for all of the clients we serve. We are welcoming of all populations including our Aboriginal partners throughout the Interior Health Region. We are committed to increasing our Aboriginal representative workforce to build an engaged, culturally diverse organization focused on the goal of providing high quality, sustainable healthcare through an engaged workforce and healthy workplaces. We build inclusive, trusting and respectful relationships through our partnerships. At Interior Health, Every Person Matters.
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