Clinical Trial Specialist

Overview:

We are seeking a highly organized and motivated Clinical Trial Specialist to play a key role in the success of our clinical trials. You will be responsible for a variety of tasks, ensuring the smooth execution of the trial from site selection to close-out.

Responsibilities:

• Site Management: Participate in site selection, initiation visits, and close-out visits, ensuring effective communication and collaboration with clinical trial sites.
• Data Integrity: Ensure optimal data quality through ongoing management of case report forms (CRFs), database review, query resolution, and frequent site data verification (SDV) and monitor visits.
• Documentation Management: Maintain accurate and complete study documentation throughout the trial lifecycle.
• Communication: Maintain clear and consistent communication with clinical site personnel to ensure timely and accurate data collection.
• Progress Tracking: Manage study progress by tracking regulatory submissions, recruitment and screening activities.
• IRB Support: Assist with central and local IRB submissions, IRB status reports, and IRB modifications.
• Patient Screening: Participate in patient screening processes, including reviewing patient eligibility and imaging data.
• Data Analysis: Lead or contribute to data analysis projects as required.
• Clinical Procedures: Participate in clinical procedures as needed, adhering to established protocols.

Qualifications:

• Education: Bachelor of Science (B.Sc.) or higher degree in Life Sciences or Biomedical Engineering.
• Experience: Experience in clinical research trials is preferred. Prior experience with interventional cardiology and medical devices is a strong advantage.
• Skills:
  • Excellent organizational and planning skills with the ability to prioritize and manage multiple tasks in a fast-paced environment.
  • Strong attention to detail and meticulous work ethic.
  • High level of motivation and a proactive approach to problem-solving.
  • Excellent communication and interpersonal skills, both written and verbal.
  • Strong teamwork and collaboration abilities.
  • Proficiency in Microsoft Office Suite (Word, Excel with functions and formulas, and PowerPoint).
  • Excellent English language skills.
  • Willingness to travel internationally as needed.