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

Thermo Fisher Scientific; Florida; Sur place; USD 70 000 - 90 000; Plein temps

Résumé du poste

Regulatory Jobs is seeking a Clinical Research Associate (Level II) to support monitoring and site management for multiple trials. You will perform remote and on-site visits, ensure regulatory compliance, and manage essential documentation across sponsors and monitoring environments.

The role emphasizes ICH-GCP adherence, data integrity, and subject protection. Travel up to 80% is expected, with requirements including a life science degree or RN certification and US work authorization.

Qualifications

• Bachelor's degree in life science or RN equivalent.
• 1–2 years of traveling on-site monitoring experience.
• Must be legally authorized to work in the United States without sponsorship.
• Must pass a comprehensive background check and drug screening.

Responsabilités

• Perform and coordinate all aspects of clinical monitoring and site management.
• Conduct remote or on-site visits to assess protocol and regulatory compliance and manage documentation.
• Ensure trial conduct per approved protocol, ICH-GCP, regulations and SOPs to protect subjects and data integrity.
• Develop audit readiness and collaborate with investigational sites.

Connaissances

Clinical monitoring

ICH-GCP

Medical terminology

Risk Based Monitoring

Communication skills

Microsoft Office

English proficiency

Presentation skills

Formation

Bachelor's degree in life science

RN certification (or equivalent)

Outils

Microsoft Office

Description du poste

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Clinical Research Associate (Level II) – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last five years.

As part of our global team, you'll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.

Education and Experience Requirements

Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship.

Valid driver's license where applicable.

1-2 years of traveling on-site monitoring experience is required.

Therapeutic experience in at least one of the following areas: Oncology, Ophthalmology, Neurology, Cardiology, Rare Disease, Respiratory, Obesity, and/or Pulmonary.

Candidates must live within 60 miles of the nearest major airport. Up to 80% travel is expected.

Must be legally authorized to work in the United States without sponsorship.

Must be able to pass a comprehensive background check, including a drug screening.

Knowledge, Skills and Abilities

• Proven clinical monitoring skills
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
• Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
• Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
• Ability to manage Risk Based Monitoring concepts and processes
• Good oral and written communication skills, with the ability to communicate effectively with medical personnel
• Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues
• Good organizational and time management skills
• Effective interpersonal skills
• Attention to detail
• Ability to remain flexible and adaptable in a wide range of scenarios
• Ability to work in a team or independently as required
• Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills

Working Conditions and Environment

• Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.
• Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Personal protective equipment required such as protective eyewear, garments and gloves.
• Exposure to fluctuating and/or extreme temperatures on rare occasions