CRA I

This is a fully remote position, open to applicants in South Africa.

📋 Description

• Oversee and coordinate all facets of the clinical monitoring and site management processes.

• Conduct remote or on-site assessments to evaluate compliance with protocols and regulations.

• Administer necessary clinical trial documentation.

• Manage procedures and guidelines from various sponsors and monitoring settings.

• Ensure that trials adhere to approved protocols, ICH-GCP guidelines, relevant regulations, and standard operating procedures (SOPs).

• Safeguard the rights and welfare of subjects while ensuring the reliability of data.

• Maintain readiness for audits.

• Foster collaborative relationships with investigational sites.

• Engage in frequent travel to site locations, typically 60–80%, which may include extended overnight stays.

• Work in office, laboratory, clinical, and/or home office settings.

• Utilize necessary personal protective equipment when in contact with biological fluids or infectious agents.

⛳️ Requirements

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

• Prior experience that provides the knowledge, skills, and abilities required to perform the job effectively.

• At least 6 months of experience in travel monitoring.

• Preferred therapeutic area experience in Respiratory (COPD, asthma, nasal polyps, etc.) and Cardiovascular.

• Valid driver's license where applicable.

• Must reside within 60 miles of the nearest major airport.

• Willingness to travel 60–80% of the time.

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

• Successful completion of a comprehensive background check, including a drug screening.

• Demonstrated clinical monitoring capabilities.

• Familiarity with medical/therapeutic area knowledge and medical terminology.

• Working knowledge of ICH GCPs, applicable regulations, and procedural documents.

• Strong critical thinking, root cause analysis, and problem-solving abilities.

• Capability to manage Risk Based Monitoring concepts and processes.

• Excellent oral and written communication skills.

• Strong customer focus, listening skills, attention to detail, and the ability to identify underlying issues.

• Strong organizational and time management skills.

• Effective interpersonal abilities.

• Flexibility and adaptability to changing situations.

• Ability to work independently or collaboratively within a team.

• Proficiency in Microsoft Office and the ability to learn required software.

• Strong English language and grammar skills.

• Proficient presentation skills.

🏝️ Benefits

• Competitive salary package.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and continuing education.

• Flexible working arrangements.

• Supportive and collaborative work environment.