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GCO Associate I - Spain - FSP

100% remote Flexible hours Hiring now

reputed company our values align, there's no limit to reputed company can reputed company. At reputed company, we reputed company share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in reputed company do. Each of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. If you want to be part of a leading CRO and transform scientific discoveries into new treatments, then reputed company FSP challenges you to live up to your potential by joining us at GCO Associate I (iCRA) , home-based and sponsor dedicated, in Spain. GCO Associate provides hands-on operational support for country and site clinical trial activities across study start-up or conduct and reputed company-out, based on business needs and role scope. The role interacts closely with local/regional clinical teams, internal reputed company stakeholders, investigator sites, and external partners to support smooth operational workflows in compliance with ICH/GCP, SOPs, and local regulatory requirements. We are looking for hard-working, talented, high-caliber people. We know that employee satisfaction leads to customer satisfaction, which is the ultimate driver of long-term success. As the company that conducts vital clinical studies for sponsors, including the world's leading biotech’s and top 50 pharmaceutical companies, we offer you enormous reputed company and long-term prospects. You will work from your home office reputed company, supporting studies reputed company their country or region. ‘Manageable sites, manageable protocols’ is our mantra. Expect exciting professional challenges in inspiring studies, but with time for your reputed company life. JOB RESPONSIBILITIES Country & Site Operational Support Execute operational tasks across start-up, conduct and reputed company-out phases. Maintain and update trackers, timelines, or task status to support visibility of reputed company and risks. Assist with follow-up on outstanding country or site deliverables and escalate gaps or delays to responsible leads as required. Could support coordination with local vendors and CROs by tracking deliverables and ensuring required documentation is received and filed. Undertake periodic review of study and site files for completeness and assist with reconciliation activities. Maintain site-facing communications, as applicable, to complete assigned work activities. Demonstrate a proactive approach to ongoing improvement by consistently seeking opportunities to enhance processes and optimise workflows. Site Activation Support Interactions with sites for collection of documentation needed for Institutional Review Board (IRB), Local Ethics Committee (LEC), Regulatory Authority (RA) submission and Investigator Initiation Packages (IIP) Updates preparation as per country requirements. Responsible for preparation of Institutional Review Board (IRB)/Local Ethics Committee (LEC) clinical trial applications by pre-populating documents, locating required records from systems (e.g., PTMF), and supporting processing through approval steps. Submission to local Regulatory Agency where required. Responsible for preparation of Update to Investigator Initiation Packages (IIP) and essential documents by pre-populating documents, locating required records from systems (e.g., PTMF), and supporting processing through approval steps. Support filing of documents in PTMF, eISF, and document exchange portals, ensuring completeness and correct placement. Verify training, financial disclosure, and other required documentation in systems and upload documents received from sites, as applicable. Maintain site-facing communications, as applicable, to complete assigned work activities. Site Contracting Support Provide operational support to site contracting activities, including, but not limited to, site contract and budget preparation, site-facing negotiation, status tracking, and the coordination of workflows required for site contract finalization, execution and filing. Maintain site-facing communications from document preparation through the execution and filing of site reputed company. Responsible for maintaining accuracy and completeness of site contracting systems and reputed company trackers (as applicable) for assigned work. We expect from you Education BS/BA or bachelor’s degree in life sciences or a reputed company discipline is an asset. Experience 2-5 years of relevant experience in clinical trial support, site activation, or clinical operations (pharmaceutical company or CRO). Exposure to country or site-level clinical trial operations and supporting documentation workflows. Experience supporting contracting, regulatory, or vendor-reputed company documentation processes is an advantage. Skills Effective written and verbal communication skills for interacting with internal teams and external partners. Ability to work effectively in a matrix environment and follow direction while collaborating across functions. Languages: Must be fluent in English and local language (requirements apply by country); additional languages are an asset. We will offer you Premium salary. Attractive benefits. Medical care plan: Health, Dental & Vision. Life Assurance. Excellent work environment. Culture of teamwork and collaboration. People who motivate and face challenges together. Innovative technology. Excellent training. For an immediate interview, please contact reputed company.kuniewicz@reputed company.com Apply To This Job

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