Clinical Research Associate II - Oncology Academy (FSP)

If you are an experienced CRA II who is looking to expand your knowledge and therapy area experience into Oncology indications then this could be the perfect opportunity.

We are currently recruiting a sponsor dedicated CRA II in Spain, who will also join our Oncology Training Academy. During this enhanced training period you'll continue to receive full pay and benefits whilst gaining hands on experience within oncology studies, dedicated to a top 50 pharmaceutical business.

Alongside your training you'll be responsible for:

Acting as liaison between the in-house team, vendors, and multiple clinical sites. Developing strong site relationships, maintaining close contact with sites by telephone, correspondence, and remote and on-site visits. Applying SOPs, Clinical Monitoring Plan (CMP), protocols, study manuals, other study materials as applicable. Help identify and qualify potential investigators. Perform Pre-Study Site Visits. Assist with start-up activities, including essential document review and collection as requested. Perform Site Initiation Visits. Provide initial and ongoing training to clinical investigators and other site staff regarding the study protocol, procedures, documentation, as well as regulatory requirements. Perform Interim Monitoring Visits for assigned studies. Monitor site compliance with study protocol and GCP. Perform source data review and verify adequacy of clinical data through comparison of case report forms to source documents per CMP. Ensure the site is entering data according to the Case Report Form (CRF) Completion Guidelines and meeting data entry and query resolution deadlines. Perform drug accountability and ensure adequate drug supply. Review research specimen sample documentation, storage and processing, and ensure shipments are sent to central lab as required. Assist study team as necessary in resolving lab queries and other issues. Collaborate with the drug safety group to ensure site compliance with serious adverse event reporting requirements. Ensure adequacy of clinical supplies to the site. Collect and review site essential documents and ensure site regulatory files are complete and accurate. Monitor site compliance with IRB policies/processes and ensure timely reporting, submissions, and approvals. Track and report progress of study, data monitoring, protocol variations, issue resolution, and follow up compliance. Ensure site staff is appropriately trained and site responsibilities are delegated to qualified staff. Perform Close Out visits as assigned. Prepare and complete visit trip reports, confirmation and follow up letters within timelines outlined in the CMP. QualificationsMore about you

On your first day we’ll expect you to have:Substantial Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.The ability to function as a mentor and role model for other CRAs.Bachelor’s or equivalent degree in biological science, pharmacy or other health related discipline.Strong interpersonal, written, and verbal communication skills within a matrixed team.Experience working in a self-driven capacity, with a sense of urgency and limited oversight. A client-focused approach to work and flexible attitude with respect to assignments/new learning.The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply your understanding of study protocol(s).An honest and ethical work approach to promote the development of life changing treatments for patients.Strong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS) and MS-Office products such as Excel and Word.

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