The In-house CRA II provides overall support to study sites and clinical project teams engaged in clinical research studies, adhering to applicable protocols, SOPs, and regulatory requirements. The role requires independent judgment and critical thinking, and the individual works independently as a study team member with minimum support in complex activities.
Requirements
- Assist with investigator recruitment activities
- Identify study sites by performing site feasibility and recruitment tasks
- Schedule internal and external meetings
- Prepare Investigator Site Files
- Perform ongoing essential document collection and review
- Act as site contact/liaison for study and site management issues
- Ensure timely and complete data entry by site in EDC or any other system
- Send email blasts/newsletter, updates, and updated study core documents to study site personnel
- Assist in providing logistics support in samples management and tracking
- Support investigators and investigative staff in fulfilling obligations regarding local submissions
- Assist in data review inclusive of site level data review, resolutions provided by sites to queries, facilitates database closure and freezing procedures
- Assist with study tracking via the CTMS, Study specific trackers or sponsor designated system
- Document site and Sponsor contact and study interactions
- Assist in remote review of the electronical Investigator Site File
- Assist with Investigational Product accountability
- Consult with project team members regarding study site issues
- Provide quality review of the amended site level informed consent template
- Follow up with sites for trial invoices and ensures the CTMS is accurately updated
- May attend site visits as needed
- May serve as an Independent Essential Document Reviewer post-SIV
- Supports on-site visits activities if needed
- May mentor an In-house CRA Trainee (New Graduate Level)
- Performs other duties as assigned by management
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Visa Sponsorship
- Four Day Work Week
- Generous Parental Leave
- Tuition Reimbursement
- Relocation Assistance
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