Senior Clinical Research Associate – Greece

Excelya is one of the leading independent CRO in Europe, it is founded in 2014 and it is a people-centered Contract Research Organization (CRO) that excels with care.

In Excelya, our mission is to offer our collaborators a human and authentic experience within a young and ambitious healthcare company that is becoming a leader in clinical research in Europe. Excelya develops, in connection with experts, scientific, managerial, and human know-how that contributes to better take into account patients’ expectations. Excelya’s vision is to achieve new advances in the field of healthcare. This includes the discovery of new molecules, new vaccines, new treatments, but also a better understanding of patient behaviors, a continuous control of regulations, and expertise in research development.

Our goal is to help our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together and to become the clinical research leader in Europe thanks to our 900 Excelyates. For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.

To learn more about us, visit www.excelya.com.

Excelya is currently seeking a Senior Clinical Research Associate (Sr. CRA) in Athens, Greece, for a full-time, permanent role.

The role:

This role is accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and client’s reputation is upheld throughout study lifecycle. It is the main client point of contact for investigative sites; accountable for site start up activities through activation; accountable for building and retaining investigator site relationships and providing support from site recommendation through the lifecycle of studies; accountable for site level recruitment and operational success, and accountable for safeguarding the quality and patient safety at the investigator site. The Sr. CRA contributes to country and site selection activities by proactively collaborating with key stakeholders and providing local intelligence to country outreach surveys, investigator strategies and client pipeline opportunities under supervision.

Job responsibilities:

• Supports processes to optimize country and site selection activities including review and assessment of the draft potential site list and provide Qualification output for site selection.
• Conducts study start up activities at the site level including but not limited to Qualification, coordination of site activation checklist items, Informed Consent Document (ICD) finalization, Site Initiation Visit (SIV), as applicable, including management of issues that may compromise time to site activation.
• Ensures all the site initiation activities completed including training per site activation checklist, collect and complete necessary documentation and systems needed.
• Supports country specific ICD review and deployment when applicable.
• Ensures follow up activities are completed post Qualification and SIV to ensure site readiness for First Subject First Visit (FSFV).
• Partners with site monitor to ensure site monitoring readiness in anticipation of FSFV.
• Acts as operational point of contact for all site level questions, liaising with and escalating to appropriate teams to respond and resolve questions.
• Reviews site monitoring reports.
• Reviews and manages site practices that differ from client practices and liaises with study management and Business Process Owners as needed.
• Maintains regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study level feedback.
• Oversees and manages of site deliverables to study targets, (i.e. data cuts and sweeps, interim analyses, database locks), helping to oversee data is up to date and any other site facing deliverables, (i.e., investigator signatures).
• Follows the study oversight plan and proactively puts in place mitigations for known and anticipated risks.
• May act as a Subject Matter Expert (SME) on client systems and processes.