Covance is growing again in Argentina! This is an exciting opportunity to join one of the fastest growing parts of our business.
If you are looking for an opportunity to develop your skills in clinical research and your long term goal is to become a CRA (Clinical Research Associate), this is a great opporutnity for you! Learn from expereinced CRAs and develop your career!
As a CRA Assistant you will act as contact for the project team and study sites. Perform CRF review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned by management.
Other duties/responsibilities include:
• Assist with generation and reconciliation of queries to investigative sites/clients to resolve problem data.
• Assist with the management of study supplies and organize shipments.
• Create, update, track, and maintain study-specific trial management files, tools, and systems.
• Assist the local project team members with other administrative activities as required (e.g. payments to investigators, correspondence with clients, preparation of status reports, and organization of investigators’ meetings).
• Co-ordinate meetings with clients, investigators, and project team, including taking minutes.
• Ensure compliance with Covance S.O.P.s, FDA, ICH, and GCP regulations for clinical conduct in all aspects of daily work.
• Provide input in writing Monitoring Conventions as assigned.
• Assist in submissions and notifications to Ethics Committees and Regulatory Authorities.
General On-Site Monitoring Responsibilities:
• Assist Senior CRAs, CRA-2 and CRA-1 with on-site tasks as required and according to training goals (e.g. review of Case Report Forms and Study File Notebook, drug accountability).
• Initiate, monitor and close out clinical investigative sites under direct supervision from Clinical Research Associates 1 and 2, Sr. Clinical Research Associates, Project Managers or Project Directors.
• Perform other duties as assigned by management.
University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 2 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.
- Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents; previous interaction with operational project teams and investigative sites.
- Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe.
- Good organizational and time management skills.
- Excellent communication/writing skills.
- Strong computer skills with an ability to access and leverage technology alternatives.
- Abilities to review/analyze relevant data so as to assist in building evidence-based clinical trial strategies.
- Self-motivation with the ability to work under pressure to meet deadlines.