The Research Coordinator is a two-year appointment and will perform all aspects of clinical trials including interim Clinical Research Ethics Board submissions, study project management, recruitment, conducting visit requirements, case record form completion, study drug accountability, and study file management in accordance with the International Council for Harmonisation (ICH) Guidance Document: Good Clinical Practice (GCP).
The Research Coordinator will work with a variety of clinical departments and health care workers at the Eye Care Centre, outpatient laboratory services, and pharmaceutical companies.
Excellent organizational and communication skills, as well as a high degree of motivation, enthusiasm, and initiative, will enable the Research Coordinator to carry out the demands of the research trials.
The UBC Department of Ophthalmology and Visual Sciences is the only academic Ophthalmology Department in the province, providing teaching to undergraduate medical students, Ophthalmology residents, postdoctoral research fellows and Ophthalmology clinical fellows both locally and internationally.
Ophthalmology Clinic
Identify potential subjects to the Principal Investigator.
Interview and provide study information to study subjects:
Be able to review the informed consent with the subject and answer questions regarding the conduct of the study with confidence.
Be able to determine when subjects should refer specific questions to the principal investigator before signing the informed consent to comply with GCP/ICH Guidelines.
Coordinates/performs diagnostic testing and exams for patients.
Establishes a positive working relationship with each subject.
Supports and teaches subjects in all aspects of their participation in the clinical trial to ensure compliance with requests and patient retention.
Clinical Trials Coordinator
Conduct and support multiple clinical trials
Conduct clinical procedures with attention to cost and budgetary requirements
Prepare, dispense, and administer study medications to subjects.
Prepare and maintain a study supply inventory and budget for multiple clinical trials
Maintain study logs for drug accountability, temperature, and others as needed
Attend investigator study meetings as required.
Data Collection and Management
Conduct visit interviews, capture appropriate data, and keep accurate records in source documents to establish a clean “paper trail” in the event of an independent audit or inspection.
Complete Case Record Forms with accuracy and neatness. Correct same as per monitor for the sponsor as required.
Prepares source documentation
Maintain study files and regulatory documents
Project Activities
Support for project design and day-to-day management of research activities and implementation of projects involving quantitative and qualitative methodologies, including of study infrastructure and development of future projects according to standard guidelines.
Supports communications, operations of programs, and in the collection of study data including recruitment, consent, conduct of interviews, and administration of study tools and data.
Study records, quality assurance, and integrity of study data.
Monitors financial processes, payments, invoicing of funds and costs, and processing of honoraria to study subjects.
Initiates and develops proposals, and grant application processes and protocols and reviews content.
Supports, and mentors team members, and provides guidance in project activities and challenges.
Ongoing coordination of study activities; day-to-day project management of timelines, resources, deliverables, and study tasks according to protocols.
Quantitative and qualitative data collection, including designing interview guides, and surveys, selecting/screening test samples, cleaning/coding data, and conducting interviews.
Supports reports, proposals, publications, presentations, manuscripts, abstracts, newsletters, posters etc
Conducts study assessments and reports; literature reviews, data analysis, etc.
Reviews and analyzes scientific data surrounding specific areas of research.
Proactively develops processes, tools (workflow, Gantt charts), and resources to support team members and projects.
Develops, implements, and refines research protocols, processes, and documentation.
May participate directly in the design, development, and inspection of technical projects, or the theoretical or applied scientific work of the department.
Interacts with multiple stakeholders from sponsoring agencies to research participants. Acts as a knowledge broker and user to add framing for policy recommendations.
Disseminate reports and presentations.
Implement policies, procedures, protocols, resources, and standards relative to all aspects of the research programs according to clinical trial protocols.
Assists in the initiation of new research, proposals, and protocols.
Writes study reports as necessary.
Contributes technical content and/or data to publications, presentations, and posters and/or produces publications, presentations, and posters and helps/participates in writing/editing papers.
Supports data analysis and interpretations.
Ensures adequate quality control, sets standards, and monitors quality control results.
Compiles data, analyzes and interprets experiment results or data.
Preparation of scientific summaries, reports, slides, presentations, and scientific manuscripts.
Maintains an appropriate knowledge base by performing regular reviews of the literature, and stays updated on procedure manuals for experimental and laboratory standards.
Writes a variety of documents such as technical and procedural sections for research reports and standard operating procedures.
Data analysis and manuscript preparation.
Ensures that the relevant research methodology is applied, and that research is in accordance with established protocols, policies, procedures strict compliance with patient/employee confidentiality practices and policies, and safety practices and standards.
Consequence of Error/Judgement The Research Manager is required to conduct all research activities in an ethical manner, suited to proper activities of the University of BC and to the professional organizations governing himself and those governing the activities of the Directors and all other investigators. Any procedures or data recorded as part of a research study must be accurate and must accurately reflect the work performed. Strict confidentiality of all study participants must be adhered to. All activities involving participants are accountable to the Principle Investigator and/or the Head.
Supervision Received Work is done independently according to established guidelines for each study, and this individual is responsible for ensuring that studies are conducted according to the principal investigator requirements as outlined for each study. This individual is accountable to the principle study investigators and reports directly to Dr. Gupta with a dotted line to the Senior Administrator.
Supervision Given The Research Coordinator may be responsible for the management of staff; and may be required to formally train and orient new staff, students, and faculty.
Minimum Qualifications Completion of a university degree in a relevant discipline or technical program and a minimum four
Tagged as: Life Sciences
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