Real Staffing Group is a global staffing and recruitment specialist providing contract and permanent talent to a wide range of companies and industries. We take time to understand your career ambitions, working with you and for you at every stage of your job search. By applying our industry knowledge to your specific requirements we aim to supply you with the most effective route to your new career opportunity. To find out more about Real Staffing Group please visit Job Description Clinical Research Associate Lead 9 months with a possibility to extend Ipsen - Cambridge, MA Objective of the mission Take responsibility for coordinating, and co-monitoring assigned clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs to the most rigorous standards of quality, timely delivery and within budget in order to assist in the delivery of Clinical Development objectives and achieve clinical excellence. Coordinate the clinical study activities within a matrix organization and the support of the Global Clinical Project Manager and the other clinical study team members. Oversee the CRO activities Key accountabilities and activities Ensure clinical activities coordination and coaching: Drive the study start-up activities by adequate oversight of the CROs/Clinical Research Associates (CRAs) activities and to ensure timely collection of essential study documents, such as regulatory and ethics committee documents for submission, and by controlling that all set up activities are performed prior to each site initiation. Support and ensure that all specific Ipsen/CRO EDC system tasks and other clinical tools under the CRA’s responsibility are completed and achieved according to the defined timelines without jeopardising the start of the trial. Assist in the training of the CRO CRAs on all study specific operational activities and participate in the organization and preparation of the monitor and investigator meetings in collaboration with the other study team members Assist in the production of and/or review all clinical monitoring documents necessary to implement, monitor and report on the study in a professional, high quality and timely manner. If study managed by CRO, validate the clinical study documents as defined in the study plans (such as study manual, monitoring plan Review and approve all/a sample of site visit reports as defined in the oversight plan, ensuring timely and appropriate follow up of issues raised by the CRAs. Conduct site co-visits /co-monitoring visits as defined in the oversight plan, identifying and solving issues in study progress, and following up as required with CRAs/investigator. Coordinate and manage the CRO relationship, assisting CRAs when and where necessary. Participate in the ongoing clinical study data reviews in collaboration with the other study team members. Make appropriate and timely reporting in CTMS (Ipsen Clinical Trial Management tracking System), with regular checks for quality and accuracy. Ensure that data collection (CRF/eCRF) progress as planned and data clarifications/queries are answered promptly by CRO CRAs, in collaboration with data-management team. Participate in TMF review regularly in collaboration with the study CTA to ensure adequate completion during the study course with a final thorough review at the end of the trial prior to study archiving Participate in the preparation and follow-up of any other study systems (such as IWRS/IMP forecasting/ flow etc…), as required. As appropriate, participate in the preparation of study documents and perform site visits prior to audits /inspection and assist in audit follow-up /findings resolution. Qualifications Experience / Qualifications - Minimum experience of 2 years in the coordination of clinical monitoring activities of international clinical development trials (PhII- PhIII)
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