CRA (Level 1) - FSP
Detail posisi
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.
Kewajiban
• Communicate the progress and relevant information or raise issues of the study to the appropriate study management team.
• Engage in effective written and verbal communication with collaborators outside the organization to ensure successful study execution.
• Accountable for local activities required in set up and for high quality execution of studies; will seek managerial or other experienced support as appropriate:
• Performs operational site evaluation visits, study initiation visits, on and off-site monitoring visits at the required frequency and site close-out visits.
• Performs site evaluation visits:
• Figures out feasibility of the study protocol with reference to study complexity.
• Confirms staff availability, suitable clinical facilities, potential for per protocol patient population. Shows the capability to follow ICH GCP and Client.
Kualifikasi
• Strong written and verbal communication skills in English and local language (if applicable), good presentation, negotiation and influencing skills.
• Able to work within remote teams and independently.
• Proficient in optimally balancing multiple responsibilities of growing scope and complexity in a fast-paced environment.
• Good social skills.
• Strong planning & organizational skills, and the ability to work efficiently and effectively in a dynamic environment.
• Respects confidentiality in terms of PII.
• Proactive, meticulous and precise in delivery of quality work even when under pressure.
• Effective at analyzing and raising issues at the right functional level, solving problems and resolving conflicts in a timely manner.
• Flexible with high learning and change agility.
• Collaborative, building strong internal and external relationships.
• Knowledge of local regulations, IND/ICH GCP - guidelines.
• Available and willing to travel as job requires.
• Proficient in using computer systems and meticulous in attention to detail.