Clinical Research Associate-Freelance
Location
Ireland
Posted
44 days ago
Salary
0
Seniority
Mid Level
No structured requirement data.
Job Description
Clinical Research Associate-Freelance
Translational Research in Oncology
Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer treatments of the future to the world of today. TRIO is looking for a Clinical Research Associate to join our Monitoring Resource team. Reporting to the CRA Line Manager, this position will be a remote full-time freelance position based in Ireland. Responsibilities: - Performing data verification of source documents; - Conducting site visits, including pre-study, initiation, monitoring, and termination; - Confirming adherence to all FDA, ICH-GCP, and local regulations; - Ensuring implementation and compliance with FDA, and ICH-GCP guidelines - Participating in budget negotiation and follow-up where applicable - Assisting with data validation and query resolution - Mentoring junior team members as required - Ensuring the completion and collection of regulatory documents Qualifications: - A minimum of 2 years of monitoring experience in oncology trials - Experience monitoring in early-phase trials will be valued. - Completion of a science-related Bachelor’s degree - Excellent knowledge of medical terminology and clinical monitoring process - Strong ICH-GCPs knowledge - Experience with clinical trial information systems - Ability to travel up to 60% on average - Must be legally authorized to work in the country Prior to applying please review TRIO's Applicant Information Notice To support efficiency, TRIO may use limited AI tools during the candidate review process. All hiring decisions are made by people, not AI. To ensure fairness and an accurate understanding of your skills, we ask that candidates refrain from using AI tools or AI‑generated responses during interviews or assessments. We want the opportunity to get to know you and your experience. Teamwork · Passion · Integrity · Innovation
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• Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV) and termination visits (TV) at assigned clinical sites and generate visit/contact reports • Oversee integrity of the study and utilize problem-solving skills to promote rapport with the site and staff • Review the performance of the trial at designated sites, ensure the rights and well-being of human subjects are safeguarded and are in accordance with protocol • Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines, while also ensuring compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s) • Evaluate the quality and integrity of the reported data, site efficacy and drug accountability • Monitor the completeness and quality of Regulatory Documentation and perform site document verification
• Targeting, influencing and qualifying the passive talent identified and presented by the Associate Search Consultant to longlist stage in the search process, acting as the expert on each project, providing analysis of market data to effectively advise and influence clients. • Alongside the Principal Consultant attend the external project calls/meetings to understand the requirements. • Contribute to the development of the search strategy, identifying appropriate sector/companies for the search and ways to identify suitable candidates. • Agree internal delivery timelines and objectives. • Through our internal search system Clockwork, updating and tracking each longlisted candidate approached and influenced throughout the process. • Adding to Clockwork high quality information for presentation of mapping, project status and longlist either as ‘live data’ or in report format. • Approaching and engaging with candidates, understanding their motivations and conducting initial assessment, qualifying candidates’ suitability according to key criteria. • Writing content rich and high-quality profiles on all longlisted individuals. • Identify and effectively gather and collate information that has a bearing on the search such as client company’s reputation, competitiveness on remuneration, market trends and the quality of available talent in the chosen area. • Writing content rich executive dashboards conveying your market findings. • Identifying and communicating any risks to the project so solutions can be sought within project timelines.
• Contributes to the selection of potential investigators • Responsible for study start-up and regulatory maintenance • Ensures the sites are always inspection ready • Manages study supplies and drug accountability at study site • Performs monitoring visits and Source Data Review


