Clinical Research Associate II

Home Based CRAII - Generous Incentive Plan 

Expanding our team due to growth. 

What you'll do: 

The primary responsibilities of this position include, but are not limited to, the following:

• Act as the routine liaison between study site and the project team for study related issues.
• Ensure protection of subjects, subjects' rights and the integrity of data through monitoring of adherence to Good Clinical Practice, applicable regulatory requirements, Standard Operating Procedures and protocol compliance
• Conduct pre-qualification, initiation, routine monitoring and close-out visits in accordance with the relevant SOPs
• Source document review and comparison to CRF data
• CRF review/retrieval and data corrections
• IMP accountability
• Maintenance of on-site investigator files
• IEC/IRB documentation
• Local laboratory documentation
• Maintenance of investigational supplies
• Reviews consent process for each subject (Informed Consent Form and source documentation)
• Verify patient eligibility
• Assess protocol compliance and deviations
• Handling of safety and efficacy issues, including, but not limited to:
• Conducts and documents onsite visits/contacts, including:
• Pre-study visits
• Initiation visits
• Routine visits
• Study completion visits
• Telephone contact
• Site visit report preparation within study specific timeframe
• Responsible for all aspects of site management as described in the study plans
• Serious adverse event reports
• Adverse event trends
• Treatment failures
• Proactively identify and resolve issues and potential site and study issues
• Assist with regulatory and study start-up activities including contract and budget negotiations, as required
• Ensure clinical data integrity and meet study timelines
• Provide ongoing updates and support to project management
• Mentor junior members of the team
• Prepare and deliver staff training sessions
• Clinical Review of individual patient listings
• Initial clinical review of comprehensive patient data listings
• Initial review of study start-up materials: SOPs, draft CRFs, completion manual, compliance forms, study prompters/calendars
• Assist in the day to day running of projects assigned
• Assist in the preparation of project specific materials e.g., status reports, newsletters, templates, etc.
• Participate in project administration as required e.g., photocopying, binder preparation, start-up pack preparation etc.
• Maintain an awareness of the literature on cancer therapy, clinical trial design and conduct, and good clinical practice
• Perform other duties as assigned by management