Clinical Research Associate – West Coast

🌍 Remote, USA 🚀 Full-time 🕐 Posted Recently

Job Description

Establish and maintain primary Sponsor communication with clinical sites for in-house and outsourced studies
Conduct oversight visits for outsourced studies to promote study engagement, enrollment and foster sponsor/site relationships
Serve as a point of contact for investigators and site staff
Maintain regular contact with study sites to ensure GCP/ICH/Protocol compliance, assessment of accrual rates
Facilitate communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables
Conduct thorough site qualifications visits
Ensure all required information concerning site/staff qualifications is clearly documented and communicated to project teams
Conduct efficient and comprehensive site initiation visits
Ensure all assigned site staff are trained appropriately, have access to the required electronic systems, and are informed of data collection, GCP, protocol and reporting requirements
Ensure monitoring visits are scheduled and performed per the Monitoring Plan and according to the performance of the clinical site and the project team needs
Maintain a flexible monitoring schedule (as appropriate) and assist in co-monitoring or monitoring support of clinical sites/studies
Conduct study specific training for new study coordinators (protocol, ICH/GCP and regulatory guidelines and study specific requirements)
Ensure all clinical site staff actively participating in the study are appropriately trained
Identify if any untrained staff are participating in Clinical trial activities, document and communicate the issues and suggested resolutions to the Clinical site and project team
Conduct device/product accountability responsibilities at clinical sites; Identify, clearly communicate and document issues to the clinical site and project team
Assist clinical site in resolving issues, if appropriate
Participate in all aspects of site close-out activities (i.e., evaluation of site readiness for final IMV, preparation for Database lock, etc.)
Communicate status of Site management activities on a routine basis to the Clinical Project team and management
Actively participate as an extended team member of the clinical study team including participating in study-specific meetings, teleconferences and investigator meetings, clear and timely communication with cross functional partners and CRA team members
Implement and execute the clinical study Monitoring Plan to ensure compliance with the plan and all assigned tasks throughout the study
Ensure clear and efficient written communication to clinical sites (confirmation letter, site visit report, follow up letter, requests for remediation or action) and project team members
Communicate project specific information to/from trial sites through teleconferences, newsletters, etc.
Work with clinical project manager to assure investigator payments are appropriate and paid on a timely basis
Document monitoring activities in monitoring visit reports and follow-up letters
Communicate serious issues to appropriate parties, in a timely manner
Ensure operational and regulatory integrity of assigned studies and participate in FDA or other regulatory authority inspections, as needed
Participate in Investigator Meetings, and other study trainings and meetings as required
Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
Support and comply with the company’s Quality Management System policies and procedures
Maintain regular and reliable attendance
Ability to act with an inclusion mindset and model these behaviors for the organization
Ability to work designated schedule
Ability to work nights and/or weekends, as needed
Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day
Ability to work on a computer and phone simultaneously
Ability to use a telephone through a headset
Ability to travel 50% of working time away from work location may include overnight/weekend travel

Minimum 4+ years clinical research monitoring experience or equivalent experience
Bachelor’s Degree in field as outlined in essential duties or Associate degree with a minimum of 6 years of monitoring experience or equivalent experience
Highschool Diploma with a minimum 8 years of monitoring experience or equivalent experience
Proficiency in data management, including progressive experience in data entry, validation, and cleaning
Familiarity with Electronic Data Capture (EDC) systems
Effective communication skills and ability to collaborate with investigators, site staff, and team members
Demonstrated ability to work well within a team and convey information effectively
Understanding of regulatory compliance to ensure adherence to applicable regulations and requirements
Knowledge and experience in informed consent procedures, adverse event reporting, documentation, and record-keeping practices
Meticulousness with a focus on accuracy and precision in all tasks and activities
Extensive experience in clinical trial monitoring, including site initiation visits, routine monitoring visits, and close-out visits
Proficiency in monitoring plans, protocol adherence, and GCP guidelines
Conducting source data verification, resolving queries, and ensuring site compliance and data accuracy
Demonstrated ability to perform the essential duties of the position with or without accommodation
Authorization to work in the United States without sponsorship.