FSP - CRA I - South Africa

ThermoFisher Scientific; United States; Hybrid; USD 65,000 - 90,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Clinical Research Associate at Level II to join our global team. You will perform monitoring visits, manage site documentation, and ensure compliance with the approved protocol and ICH-GCP guidelines.

The role emphasizes collaboration with sponsors and diverse monitoring environments. The position requires a life science degree or nursing certification, with travel up to 60-80% and ability to work remotely or on-site as needed.

Qualifications

• Proven clinical monitoring skills and knowledge of medical terminology.
• Ability to apply ICH-GCP guidelines and regulations.
• Strong written and verbal communication abilities.
• Willingness to travel up to 60-80%.
• Flexible and able to work independently or in a team.

Responsibilities

• Perform and coordinate all aspects of clinical monitoring and site management.
• Conduct remote or on-site visits to assess protocol compliance.
• Manage documentation across sponsors and monitoring environments.
• Ensure audit readiness and subject safety.
• Maintain relationships with investigational sites and stakeholders.

Skills

Clinical monitoring

ICH GCP knowledge

Regulatory compliance

Communication skills

Time management

Microsoft Office

English language

Education

Bachelor's degree in life sciences or RN certification

Tools

Microsoft Office

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as an FSP Clinical Research Associate Level I - Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotech, 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 6 months minimum of travel monitoring is required)

Therapeutic areas preferred-> Respiratory (COPD, asthma, nasal polyps, etc.) & Cardiovascular.

Valid driver's license where applicable.

Candidates must live within 60 miles of the nearest major airport. 60- 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 flexibile 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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.