Research Coordinator

University of British Columbia•Vancouver, BC

1d•Onsite

About The Position

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.

Requirements

Completion of a university degree in a relevant discipline or technical program and a minimum four years of related experience or an equivalent combination of education and experience.
Willingness to respect diverse perspectives, including perspectives in conflict with one’s own
Demonstrates a commitment to enhancing one’s own awareness, knowledge, and skills related to equity, diversity, and inclusion

Nice To Haves

Master’s degree with five years of relevant experience in a related health care field, or demonstrable equivalent combination of special skills and experience.
Experience as a clinical research coordinator involved with multiple clinical trials.
Experience in all phases of clinical trials from the initial clinical ethics application through to subject consent and conducting the clinical trial per the sponsors’ protocol while ensuring the subjects’ rights and safety throughout the trial.
A thorough understanding of the requirements of the UBC Clinical Research Ethics Board Guidelines for clinical trial application is essential, as is a good understanding of the Health Canada Division 5 of the Food and Drug Regulations and the ICH/GCP guidelines.
Strong organization with attention to detail including experience with scheduling complex appointments involving many hospital departments and treatment requirements.
Excellent communication and interpersonal skills.
Capacity to work independently and as a team member.
Comprehensive knowledge of ophthalmology treatment and pathology.
Management of multiple projects simultaneously.
Empathetic personality with concern for patients’ needs.
Computer literacy with Windows, Microsoft Excel, Word, and PowerPoint, and ability to interface with research-related software as needed.

Responsibilities

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.
Prepare documents required for a clinical trial application for the UBC Clinical Research Ethics Board in consultation with other members of the clinical trial team.
Prepare additional documents/tools to aid in administrating and delivering study protocol, including appropriate SOPs and working practices documents to capture clinical data per the sponsor’s protocol
Liaison with various departments required to conduct subject examinations and treatments.
Prepare schedule of visits required and book appointments accordingly.
Inform subject of visits and confirm appointments to assure compliance of protocol.
Manage photography tracking documentation and send electronic images as required
Prepare and present information on retinal conditions to the subject population and/or interested groups as required.
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.
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
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, and procedures strict compliance with patient/employee confidentiality practices and policies, and safety practices and standards.