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Clinical Research Associate-Specialist
Our Client is searching for a Clinical Research Associate located in Marlboro, MA. This is a temp to hire role in the Biotech industry.
Responsible for supporting the initiation, monitoring, and closing out of clinical study sites for assigned projects in order to ensure study milestones are met. Central point of communication and document control between our client and investigational sites for all clinical trial related activities.
- Conducts site initiation, interim monitoring and close out visits at assigned clinical sites and continues to train study personnel as needed on eCRF completion and study procedures.
- Maintains Trial Master Files to internal standards and regulatory requirements.
- Resolves queries of eCRF data with study site personnel.
- Creates CDAs and assures fully executed forms are returned.
- Creates and maintains project specific spreadsheets as directed by project management.
- Maintains tracking and reconciliation of investigator payments.
- Assists other team members with site-specific issues, acting as liaison between study staff and project staff.
- Attends and records minutes for internal Clinical meetings.
- Prepares presentations with advanced skills in PowerPoint.
- Conducts feasibility survey of potential sites via email or telephone.
- Follows all company safety policies & other safety precautions within work area.
- Regular attendance and timeliness is essential.
- Bachelor’s degree or equivalent experience supporting clinical trials for medical devices diagnostics, or pharma
- Minimum 1 to 2 years’ experience as a CRA required. Previous monitoring experience required.
- Understanding of management of clinical site activities with knowledge of when to escalate issues to management or clinical team
- Excellent oral and written communication skills.
- Advanced computer proficiency, especially MS Office
- Ability to multi-task and prioritize projects, site questions, and clinical team inquiries while managing responsibilities and deadlines.