CRA II/ Sr CRA I/ Sr CRA II - US Southeast Region - Multiple Therapeutic Areas Available

Thermo Fisher Scientific • Miami Beach, FL

19d

About The Position

As a Clinical Research Associate (Level II), you will perform and coordinate clinical monitoring and site management activities. You will conduct remote and on-site visits to assess protocol and regulatory compliance and manage required documentation. The role involves managing procedures and guidelines across different sponsors and monitoring environments, including FSO, FSP, and Government settings.

As a site processes specialist, you will help ensure trials are conducted according to approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs, protecting subjects’ rights and well-being and supporting reliable data. You will maintain audit readiness and develop collaborative relationships with investigational sites. Detailed assigned tasks and responsibilities are outlined in the task matrix.

Requirements

• Bachelor’s degree in a life science-related field, Registered Nursing certification, or equivalent relevant formal academic or vocational qualification.
• Experience comparable to one year as a clinical research monitor, or completion of a PPD Drug Development Fellowship.
• One to two years of on-site monitoring travel experience.
• Therapeutic experience in at least one of these areas: Oncology, Ophthalmology, Neurology, Cardiology, Rare Disease, Respiratory, Obesity, or Pulmonary.
• Valid driver’s license where applicable.
• Live within 60 miles of the nearest major airport.
• Be legally authorized to work in the United States without sponsorship.
• Pass a comprehensive background check, including drug screening.
• Demonstrated clinical monitoring skills and understanding of medical or therapeutic areas and medical terminology.
• Ability to attain and maintain working knowledge of ICH-GCPs, applicable regulations, and procedural documents.
• Critical thinking, investigation, root-cause analysis, and problem-solving skills.
• Ability to manage Risk Based Monitoring concepts and processes.
• Good oral and written communication skills, including the ability to communicate effectively with medical personnel.
• Customer focus, listening skills, attention to detail, and ability to identify customers’ underlying issues.
• Good organizational, time-management, and interpersonal skills.
• Flexibility and adaptability, and ability to work independently or as part of a team.
• Solid knowledge of Microsoft Office and ability to learn appropriate software.
• Good English language, grammar, and presentation skills.

Responsibilities

• Perform and coordinate clinical monitoring and site management activities.
• Conduct remote or on-site visits to assess protocol and regulatory compliance.
• Manage required clinical trial documentation.
• Manage procedures and guidelines across different sponsors and monitoring environments.
• Help ensure trials comply with approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs.
• Support protection of subjects’ rights and well-being and the reliability of trial data.
• Ensure audit readiness.
• Develop collaborative relationships with investigational sites.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level