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
