Sr CRA (Level I)

at  Thermo Fisher Scientific

JOB DESCRIPTION

Are you ready to advance your research career? Thermo Fisher Scientific Inc. is seeking a highly skilled Sr CRA (Level I) to join our world-class team in Indonesia. As a leading global healthcare company, Thermo Fisher Scientific is dedicated to empowering our customers to create a healthier, cleaner, and safer world.

REQUIREMENTS:

• Bachelor’s degree in a scientific field or a related area, or equivalent experience.
• Proven experience as a Clinical Research Associate (CRA) in the pharmaceutical or biotechnology industry
• In-depth knowledge of GCP, ICH guidelines, and regulatory requirements
• 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.
• Available and willing to travel as job requires.
• Strong computer skills with good eye for detail.
  Join us at Thermo Fisher Scientific, where we value diverse experiences, backgrounds, and perspectives. We are an equal opportunity employer and offer reasonable accommodations for applicants with disabilities during the job application process.

• Communicate the progress and information or raise issues to the study management team.
• Accountable for activities required in set up and for quality execution of studies
• Perform site selection, initiation, monitoring, and closeout visits
• Confirms staff availability, facilities, for per protocol patient population.
• Confirms ability to align with ICH GCP and Client requirements for clinical studies and works with Client Study staff to carry out a study / site level risk assessment.
• Delivers training to site staff and parties, as the need arises. Assists with web based and face to face Client trainings to ensure that investigators and site staff are appropriately trained in ICH GCP and study related procedures so that they can effectively be responsible for the study.
• Ensure data accuracy, integrity, and compliance with Good Clinical Practices (GCP) and regulatory guidelines
• Collaborate with cross-functional teams to successfully implement clinical trials
• Maintain relationship with sites and ensure that study timelines related to monitoring activities are achieved and that recruitment targets, patient recruitment cycle times, data and audit quality and site related achievements are met.
• Ensure that investigators and staff fully understand their roles and responsibilities with respect to requirements (ICH-GCP).
• Ensure Investigator and site staff receives safety reports and new safety information in a timely manner.
• Ensure the accuracy of data collected for safety reporting (AEs, SAEs etc.), and provides such information to relevant departments, within the required time frames.
• Ensure all vital study supplies are available at sites in a timely manner and appropriate accountability is maintained during the study. Ensure all unused study supplies are accounted for and destroyed appropriately.
• Ensure sponsor study records are inspection ready at all times and archives records as applicable.