As Senior CRA you will function as a leader for projects and assume line management responsibilities.
You will be responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; act in the project role of Local Project Coordinator or Lead CRA as assigned.
- Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned;
- Review progress of projects and initiate appropriate actions to achieve target objectives;
- Organize and make presentations at Investigator Meetings;
- Interact with internal work groups to evaluate needs, resources and timelines;
- Act in the project role of Local Project Coordinator or Lead CRA as assigned;
- Site administration and site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP;
- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor;
- Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs;
- Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned;
- Assist with training, mentoring, and development of new employees, e.g. co-monitoring.
Required experience, skills and education:
- Excellent site monitoring and management skills;
- Minimum four years of relevant clinical research experience in pharmaceutical or CRO industries;
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements;
- Ability to train and supervise junior staff;
- Ability to work under minimal supervision;
- University Degree (life science) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology);
- Fluency in local and English language.
In return, we offer you the opportunity to develop your career with an international organization; to pursue further training and to take advantage of our flexible conditions and attractive remuneration package.