What We Do
Care Access is a unique, multi-specialty network of research sites that operates
as one connected team of physician investigators, nurse coordinators, and
operations managers.
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 Clinical Research Coordinator’s primary responsibilities are to utilize Good
Clinical Practices (GCP)s in the process of screening, enrolling and closely
monitoring clinical research study subjects while ensuring protocol and
regulatory compliance.
What You'll Be Working On
Duties include but 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
personnel.
• Interact in a positive, professional manner with patients, sponsor
representatives, investigators and Care Access personnel and management.
• Communicate clearly verbally and in writing.
Patient Coordination:
• Prescreen study candidates
• Obtain informed consent per Care Access 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.
• Perform other duties as assigned. The duties and responsibilities listed above
are representative of the nature and level of work assigned and are not
necessarily all-inclusive.
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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 (
