Research Analyst
Cybermedia Technologies, LLC (CTEC)
Python
Clinical Research Associate – West Coast
ProPharma
full-time
Posted on:
Location Type: Remote
Location: Remote • California • 🇺🇸 United States
Visit company websiteJob Level
JuniorMid-Level
Tech Stack
Google Cloud Platform
About the role
- 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
Requirements
- 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.
Benefits
- Diversity, equity, and inclusion initiatives
- Opportunities for professional development
- Flexible working environment
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical research monitoringdata managementdata entrydata validationdata cleaningElectronic Data Capture (EDC)informed consent proceduresadverse event reportingsource data verificationGCP guidelines
Soft skills
effective communicationcollaborationteamworkmeticulousnessaccuracyproblem-solvingflexibilityinclusion mindsettimely communicationaccountability
