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The company is looking for a Clinical Research Associate to support and observe clinical site monitoring services, ensuring protocol, SOP, and regulatory compliance for full-service studies. The role aims to improve investigative site performance, patient recruitment, and data accuracy.

Requirements

• Conduct remote data review, support data query and closure activities, support Risk Based Monitoring (RBM) activities, assess data collection and (regulatory) document collection, perform remote activities for investigational sites in accordance with corporate, sponsor and regulatory (ICH GCP and other) standards and guidelines.
• Serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per SOPs, Monitoring Plan and study guidance, including creating contact reports for each telephone session (outbound or inbound) with sites.
• Manage and file site specific documents in (e) TMF.
• Assist Clinical Research Associates (CRA) with preparation for site visits (i.e. running reports, QC of files and checking for missing documents in the TMF, resolving action items and queries from previous visits).
• Perform Case Report Form review, query generation and resolution against established data review guidelines and the monitoring plan.
• Monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA.
• Assist with the coordination of study visits, shipment study supplies and system access or updates.

Responsibilities

• Conduct remote data review, support data query and closure activities, support Risk Based Monitoring (RBM) activities, assess data collection and (regulatory) document collection, perform remote activities for investigational sites in accordance with corporate, sponsor and regulatory (ICH GCP and other) standards and guidelines.
• Serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per SOPs, Monitoring Plan and study guidance, including creating contact reports for each telephone session (outbound or inbound) with sites.
• Manage and file site specific documents in (e) TMF.
• Assist Clinical Research Associates (CRA) with preparation for site visits (i.e. running reports, QC of files and checking for missing documents in the TMF, resolving action items and queries from previous visits).
• Perform Case Report Form review, query generation and resolution against established data review guidelines and the monitoring plan.
• Monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA.
• Assist with the coordination of study visits, shipment study supplies and system access or updates.

Other

• Represents the corporation by maintaining collaborative relationships with stakeholders.
• Act as the first point of contact for site when the CRA is absent.
• Support patient recruitment providing guidance to site teams of inclusion/exclusion criteria.
• Support and observe primary assigned CRAs at both onsite and remote visits.
• Undergraduate university degree (Bachelor or Honors Bachelor), & 1-3 years' related experience with initial and On-going training.