Clinical Research Associate
4 weeks ago
Our client located in Bedford, MA is looking for a Clinical Research Associate to join their team on a direct hire basis. This role offers a hybrid work schedule.
Responsibilities:
- Serve as primary in-house site contact through all phases of the clinical study from startup through close out activities including site selection, site qualification, site initiation, subject enrollment and follow-ups and close-out as required.
- Regularly track and communicate study status to Study Team, Supervisor and Upper Management
- Create study specific processes, clinical documentation trackers and guidance documents.
- Assist in the review, editing, execution, submission and tracking of study documents for IRB Approval.
- Assist in the review and editing of informed consents forms (ICF) and completion of the ICF checklist for final review by the Sr. Clinical Project Manager (PM).
- Create and revise study specific materials, such as source worksheets, study specific training slide presentations and essential document templates as requested by study PM.
- Manage and track the review and execution process for site contracts, contract amendments and budgets.
Experience:
- Bachelor’s Degree and minimum 3 years clinical affairs related experience.
- Experience with clinical operations as a CRA working on multiple studies from site selection through study close-out.
- Experience working effectively in small cross-functional teams.
- Proficient in the use and management of electronic TMF systems.
- Proficient in Google Workspace/Microsoft Office (Word, Excel, PowerPoint), CTMS software and comfortable with EDC systems.
- Knowledge of US Regulations, ISO standards, GCP, GDP, and ICH Guidelines
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