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Clinical Trials Assistant
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¿ Assist with the creation and maintenance of documentation for a given clinical trial/s study or studies including: training materials, operations/regulatory/pharmacy/other binders, monitoring plans, presentations, reports, and journal articles. Create study materials, essential documents, presentations, reports, submissions, articles, and other materials based on existing templates.
¿ Establish and maintain the CTMF. Under the supervision of the CRA, review the CTMF for compliance for a given trial/s.
¿ Establish and maintain the CTMS and other tracking tools for a given trial/s. Produces reports from tracking systems as required.
¿ Prepare meeting agendas, minutes, and tracks action items from various meetings as assigned.
¿ Responsible for accurate distribution of all clinical trial related materials to clinical trial sites or clinical team/CRA members.
¿ Increasingly independent assistance with data cleaning activities such as CRF review, listings production and review, and query generation.
¿ Assist CRA in preparation for clinical trial site monitoring visits.
¿ Perform all duties and responsibilities in accordance with CFR, GCP/ICH.
¿ Create study materials, essential documents, presentations, reports, submissions, articles, and other materials based on existing templates.
¿ Under the supervision of the Protocol Lead may review Informed Consent documents and/or regulatory documents for compliance using approved SOPs, checklists and templates.
¿ Increasing responsibility for assisting with the conduct of clinical team meetings, including agenda preparation, minutes, and action item tracking.
¿ Routinely contact clinical trial site staff to obtain information and document appropriately.
¿ Interface with Clinical Research Organizations and study vendors to ensure successful clinical trial conduct as required.
¿ Increase basic knowledge of scientific, medical and therapeutic information.
¿ May assist in the preparation and follow-up of in-house and on-site company sponsored quality audits, as well as, regulatory authority inspections.
¿ Adhere to Clinical Operations or project specific quality documents (e.g. SOPs, work practices, training guides), as applicable.
*Sponser side experience preferred.
Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit Aerotek.com.