Clinical Research Coordinator, RN

• 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

• Working knowledge of medical and research terminology
• Working knowledge of federal regulations, good clinical practices (GCP)
• Excellent phlebotomy skills
• Ability to communicate and work effectively with a diverse team of professionals.
• Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals.
• Ability to work independently in a fast-paced environment with minimal supervision.
• Strong organizational skills: Able to prioritize, delegate, direct, support, assign and evaluate others work and follow through on assignments.
• Communication Skills: Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients, and vendors.
• Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals.
• Strong computer skills
• Ability to balance tasks with competing priorities.
• Critical thinker and problem solver.
• Curiosity and passion to learn, innovate, able to take thoughtful risks and get things done.
• Friendly, outgoing personality; maintain a positive attitude under pressure.
• High level of self-motivation and energy.
• Ability to work independently in a fast-paced environment with minimal supervision.
• Must have a client service mentality.

• A minimum of 1 year of relevant work experience required.
• RN license in good standing required.
• Phlebotomy and infusion experience required.
• Clinical Research Experience preferred.

• Location: Cape Breton, Canada
• Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.

• 6 weeks paid vacation annually
• Access to group health benefits plan for self and dependents
• Voluntary group RRSP retirement plan with matched contributions

Care Access