What We Do
Care Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physicians and patients to 3%. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies.
Who We Are
We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.
Position Overview
The CRC I, RN conducts delegated clinical tasks and monitoring of research participants in accordance with Good Clinical Practices (GCP), ensuring protocol and regulatory compliance.
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What You'll Be Working On (Duties include but are not limited to):
Ability to understand and follow institutional SOPs
Review and assess protocol (including amendments) for clarity, logistical feasibility
Ensure that all training and study requirements are met prior to trial conduct
Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff
Assist with planning and creation of appropriate recruitment materials.
Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database
Actively work with recruitment team in calling and recruiting subjects
Attend Investigator meetings as required
Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
Assist in the creation and review of source documents
Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)
Study Management:
Prioritize activities with specific regard to protocol timelines
Maintain adherence to Health Canada Division 5 regulations and ICH guidelines in all aspects of conducting clinical trials
Maintain effective relationships with study participants and other care Access Research personnel
Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management
Communicate clearly verbally and in writing
Patient Coordination:
Prescreen study candidates
Obtain informed consent per Care Access Research SOP
Complete visit procedures in accordance with protocol
Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion
Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)
Documentation:
Record data legibly and enter in real time on paper or e-source documents
Accurately record study medication inventory, medication dispensation, and patient compliance
Resolve data management queries and correct source data within sponsor provided timelines
Assist regulatory personnel with completion and filing of regulatory documents
RN specific duties:
Preparation and administration of Investigational Product (IP; study drug)
Monitor participant for adverse reactions
Communicate regularly with PI
Maintain a clean work area
Comply with Safety and PPE standards.
Perform phlebotomy and insert IV catheters
Conduct delegated clinical procedures as required per protocol.
Comply with regulatory requirements, policies, procedures, & standards of practice
Receipt and proper storage of investigational products
Maintain Investigational Product records in accordance with regulations and sponsor requirements
Maintain the blinding of all study products where required.
Maintain proper storage, security and temperature for all medications and investigational products
Maintain appropriate research training and RN licensure in good standing in the province of Clinical Trials activities
Physical and Travel Requirements:
This is an on-site position with regional commute requirements. Regularly planned travel within the region will be required as part of the role. Overnight travel will be minimal (
