Senior Clinical Research Associate (Sr. CRA)

<p>Job Description</p><p></p><p>We are currently looking for a:<br/> </p><p><b>Senior Clinical Research Associate (Sr. CRA)</b><br/> </p><p>The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA-Manager, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company’s policies and procedures, quality standards and adverse event reporting requirements internally and externally.</p><p>Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.</p><p>Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems.</p><p></p><p><b>Responsibilities:</b></p><ul><li><p>Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.</p></li><li><p>Performs clinical study site <span>management/monitoring</span> activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws &amp; Regulations, Protocol, Site Monitoring Plan and associated documents.</p></li><li><p>Coordinates &amp; manages various tasks in collaboration with other sponsor roles to achieve Site Ready.</p></li><li><p>Performs remote and on-site monitoring &amp; oversight activities using various tools to ensure:</p><ul><li><p>Data generated at site are complete, accurate and unbiased.</p></li><li><p>Subjects’ right, safety and well-being are protected.<br/> </p></li></ul></li><li><p>Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit &amp; non-visit contact reports appropriately in a timely manner.</p></li><li><p>Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.</p></li><li><p>Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA-Manager, CRM, TA Head and CRD as needed.</p></li><li><p>Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.</p></li><li><p>Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.</p></li><li><p>Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as <span>appropriate/required.</span></p></li><li><p>Following the country strategy defined by CRD and CRA-Manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.</p></li><li><p>Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate.</p></li><li><p>Could perform Quality control visits if delegated by other roles and trained appropriately</p></li></ul><p></p><p><b>Qualifications:</b></p><ul><li><p>Associate’s degree, certificate or equivalent in a scientific / healthcare discipline together with at least 7 years of relevant experience in the healthcare field, including at least 4 years of direct site management (monitoring) experience in bio / pharma / CRO.</p></li><li><p>Alternatively: Bachelor’s degree (or above) with at least 4 years of direct site management (monitoring) experience in a bio / pharma / CRO.</p></li><li><p> Fluent in Greek and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.</p></li><li><p>Ability to travel domestically and internationally approximately 65%-75% of working time (Expected travelling ~2-3 days/week)</p></li><li><p>Valid driver’s license</p></li><li><p>Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH &amp; country clinical research law &amp; guidelines.</p></li><li><p>Hands on knowledge of Good Documentation Practices.</p></li><li><p>Proven Skills in Site Management including independent management of site performance and patient recruitment.</p></li><li><p>Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.</p></li><li><p>Able to work highly independently across multiple protocols, sites and therapy areas.</p></li><li><p>High sense of accountability / urg