Job Overview
Support clinical research activities associated with the development of a new and innovative medical device. Responsible for clinical, technical and administrative tasks, to ensure integrity of clinical data in adherence to all applicable regulatory guidelines and Standard Operating Procedures %28SOPs%29.
Job Description
- Conduct site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Ensure copies/originals %28as required%29 site documents are available for filing in the Trial Master File %28TMF%29 and verify that the Investigator%27s Site File %28ISF%29 is maintained in accordance with GCP and local regulatory requirements.
- Communicate with the clinical site staff how to coordinate and manage the research activities
- Maintain documentation files and database of clinical investigation projects
- Verify that study staff is adequately trained and perform training as needed.
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
50-70% of work will be onsite.
Education:
- Degree in healthcare or life science related field with relevant experience.
- Certified Clinical Research Associate %28CRA%29.
- Valid Good Clinical Practice %28GCP%29 certification.
Skills & Experience
- English – professional working proficiency or above
- 1-3 years%27 experience in clinical research
- Working knowledge of GCP/ICH and investigational product regulations
- Knowledge of medical terminology
- Experience in operation /project management
- Very good interaction with patients /customer
- Proficiency with Electronic Data Capture systems, Microsoft Office %28Word, Excel, PowerPoint%29 to support the effective conduct of the clinical studies
- Must have a car, valid driver’s license and the ability to commute to clinical sites
- Working in a startup environment – an advantage
- Experience in the cardiovascular or pulmonary space – an advantage
Competencies :
- Excellent teamwork skills and good human interface
- Consistent attention to details ,well organized and good problem-solving & organizational skills
- Agile mindset, and Out of the box mindset
- Sense of urgency, take A-Z ownership
- Ability to self and fast learning
- Independent
