Research Coordinator in the Renal Transplant Research Group
Providence Health Care Research Institute (PHCRI)
An exciting opportunity has come up for a Research Coordinator in the Renal Transplant Research Group.
The Clinical Research Coordinator will be coordinating, communicating and managing numerous industry and grant funded clinical trials and projects focused on kidney diseases. The individual will perform all aspects of clinical trials administration including ethics applications, recruitment strategies, subject monitoring, oversight of case report form completion and study file management.
The position involves working in an office/clinic environment with computerized equipment.
This position receives direction from the principal investigators. The coordinator is required to exercise initiative and judgment in establishing priorities and carrying tasks through to completion.
The clinical research coordinator must perform duties according to GCP guidelines and be independently motivated, organized, and detailed oriented. The coordinator is required to conduct all research activities in an ethical manner, suited to the proper activities of the University of British Columbia and those governing the activities of the institution. The incumbent must ensure accuracy of regulatory documents and application forms. Strict confidentiality of all study documents must be adhered to. Breaches in confidentiality, inattention to detail could have significant effect on the integrity of the research, which could impact funding and the reputation of Investigators.
- Conducts and manages multiple clinical trials to ensure smooth implementation of study from beginning to completion.
- Drafts clinical trial ethics applications and develops ethical consent forms for clinical research studies by the appropriate committees, mainly PHC research ethics board.
- Identifies and recruits potential research subjects and determines the participation eligibility.
- Responsible for the submissions of ethic approval, clinical trials approval, renewals, amendments, acknowledgements, protocol deviations, and adverse event reports.
- Prepares, composes and edits research documents.
- Prepares source documentation for clinical studies.
- Conducts visit interview, reviews and synthesizes data in source documentation.
- Oversees case report form completion, is responsible for data collection and data corrections to ensure data integrity and consistency.
- Educates subjects of their involvement in all aspects of their participation in the clinical study; answer questions or refer specific questions to the PI.
- Liaises with pharmaceutical companies, Contract Research Organization’s, clinical trial monitors, investigators and research staff to ensure the smooth operation of clinical trials and to ensure the protocol is followed.
- Evaluates staffing needs to ensure adequate operation for clinical trials.
- Ensures compliance to GCP/ICH guidelines and protocol adherence.
- Oversees the setting up and maintenance of study files, regulatory documents, and subject files.
- Some clinical research experience or the equivalent combination of education and experience.
- Have a positive attitude and a willingness to learn.
- Experience in a critical care environment is desired.
- Proficient working knowledge of the Microsoft Office suite, specifically Word, Excel and electronic communications.
- Ability to manage time effectively and determine priorities.
- Compile, organize and store data for investigators.
- Ability to work well individually and with others in a team setting. Must be able to interact well with others (investigators, nurses, coordinators, site monitors), great interpersonal skills, communication and leadership.
- Ability to exercise good judgement, prioritize workload and work efficiently under pressure to meet deadlines.
- Demonstrated ability to maintain high level of efficiency, accuracy and attention to detail.
- Ability to exercise initiative and maintain confidentiality.
- Ability to work a flexible schedule.
- Self directed, with effective oral and written communication, analytical, problem-solving, and organizational skills.
Work hours: Full time, Monday to Friday, flexible
How to apply: Interested candidates should email their resume with cover letter directly
Job Type: Full-time