The Clinical Research Nurse Coordinator 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 ICH/GCP guidelines.
The Clinical Research Coordinator will work with a variety of clinical departments and health care workers at the VH/UBC Eye Care Centre, VGH, 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 Clinical Research Coordinator to carry out the demands of the research trials.
- 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 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 prior to 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.
- Coordinate study activities:
- 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 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.
- Clinical Trials Coordinator
- Conduct and manage multiple clinical trials
- Conduct clinical procedures with an attention to cost and budgetary requirements
- Assist in development and management of study budgets
- 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 interview, capturing appropriate data and keep accurate records in source documents to establish a clean “paper trail” in 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
EXERCISING JUDGEMENT/IMPACT OF DECISIONS
An independent worker who is capable of exercising good clinical judgment in assessing subjects for study recruitment as per their ability to fulfill the study requirements while being sensitive to the needs of the individual. A team player realizing the contribution of all participants involved in the clinical trial process have an essential role and working together will contribute to the success of clinical trials and patient outcomes.
MINIMUM QUALIFICATIONS & SKILLS
- High school graduation, post secondary training in a related health care field, experience in management of office procedures and a patient population.Prior experience and recommendation from a clinical trial setting.
- Experience as a clinical research coordinator involved with multiple clinical trials. This experience must include 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 a good understanding of the Health Canada Division 5 of the Food and ICH-GCP.
- Experience with scheduling complex appointments involving many hospital departments and treatment requirements. These appointments are dependent on the individual clinical trial protocols and it is essential the schedule be adhered to in a timely manner.
- Excellent communication skills with all departments and the subjects themselves in order to keep the visit requirements per protocol and therefore not incur any inconvenience to the subject.
- This individual will have an in-depth working knowledge of assisting with medical procedures.
- Computer competency in Windows, Microsoft Excel, Word and Power Point.
Job Types: Full-time, Part-time