Clinical Research Associate

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