CTA - outsourced to niche Biotech via small CRO

​RBW Consulting are partnered with a growing, small sized CRO in their search to find a CTA to be outsourced to one of their most trusted clients - a niche Biotech.

You will be working on Clinical Trials by assisting the Clinical Trial Manager with the conduct on you assigned studies, focusing on administration, coordination, and archiving. You will also assist with the inspection readiness of the Electronic Clinical Operations system for your assigned trials. You will report directly in to the CTA Manager.

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Responsibilities

• Assist the CTM with the coordination of the logistical aspects of the assigned trial, according to GCP and the applicable SOPs

• Develop and adapt documents to trial specific requirements in collaboration with the CTM

• Assist with organizing (agenda, meeting minutes, follow-up on action items) trial specific meetings, including but not limited to trial team meetings and Investigator Meetings

• Coordinate the filing of TMF documents in the eTMF part of ECO by reviewing completeness and correct use of ECO. Follow-up with the CTT on findings and provide support on how to use ECO.

• Act as Business Administrator in the eTMF system, by maintaining records and supporting close-out activities (including archival preparation) in the eTMF system. This includes: managing study records, country records and site records.

• Assist the CTM/COL to ensure that the Trial Operations TMF Documents are properly filed and made ready for archiving.

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Skills

• Fluency in English

• Extensive knowledge of ICH-GCP

• 1+ years of experience within Clinical Operations, preferably in a CTA role

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Please apply here and Harry Henson will be in touch!