In accordance with the Mission, Vision and Values, and strategic directions of Provincial Health Services Authority patient safety is a priority and a responsibility shared by everyone at PHSA, and as such, the requirement to continuously improve quality and safety is inherent in all aspects of this position. The Clinical Research Coordinator, plans, manages, and communicates the administration of research activities. This role manages patient recruitment, screening, database management, online Research Ethics Board (REB) submissions and other research activities. It includes the responsibility for managing research budgets and furthering funding opportunities to advance research endeavors. The focus of research includes sponsor-driven studies and investigator or longitudinal sponsor driven studies to advance medical knowledge, evaluation of technology and optimization of patient care.
Duties/Accountabilities:
- Plans and oversees set-up and day-to-day activities related to clinical trial initiation and/or management, including liaising with hospital staff and collaborating researchers, procuring study equipment and materials, subject recruitment and follow-up, tracking study progress, creating and maintaining study databases and troubleshooting study related problems. Communication and approval from clinical operators when required.
- Assists in research proposal and protocol development and collaborates on grant applications to facilitate project funding and liaise with funding sources. Drafts and manages budgets and detailed scopes for studies. Assists in preparing and editing manuscripts and presentations.
- Ensures adherence to appropriate procedures and practices for patient consent and ethical review in studies by following good clinical practice (GCP); including standard operating procedures (SOP) development, REB applications and meeting Health Canada regulatory and industry sponsor requirements.
- Supervises, schedules and trains research assistants, volunteers and medical students and facilitates residents or trainees in conducting research. Makes recommendations with respect to hiring and provides input into staff performance.
A level of education, training, and experience equivalent to a recognized Bachelor’s program in an appropriate health related discipline plus 3 years of recent related experience in a clinical research setting.
Proficiency in patient interview techniques, research subject counseling, database management and online Research Ethics Board submissions. Ability to work on all phases (I-IV) of clinical development, Health Canada documentation and Sponsor monitoring visits. Ability to accept responsibility and work independently under minimal supervision. Solid judgment and a proven ability to maintain confidentiality, tact and discretion in interactions and in handling information. Demonstrated computer literacy in Word, Excel, PowerPoint, Outlook, and Internet. Effective organizational skills, including ability to prioritize work, multi-task, and to meet deadlines and schedules. Demonstrated ability to maintain a high degree of accuracy and attention to detail. Effective in interpersonal, analytical, problem-solving and organizational skills. Ability to work on multiple projects without compromising the integrity of each project.