FSP CRA I, CRA II – Oncology, Respiratory, Cardiovascular

This is a fully remote position, open to applicants in Alabama, +8 more states.

📋 Description

• Oversee and coordinate all elements of the clinical monitoring and site management process.

• Perform remote or on-site visits to evaluate compliance with protocols and regulations.

• Manage essential clinical trial documentation.

• Handle procedures and guidelines from various sponsors and monitoring environments.

• Serve as a specialist in site processes.

• Ensure that trials adhere to approved protocols, ICH-GCP guidelines, relevant regulations, and SOPs.

• Safeguard the rights and well-being of subjects and ensure the reliability of data.

• Maintain readiness for audits.

• Cultivate collaborative relationships with investigational sites.

• Travel frequently to site locations, typically 60–80% of the time, 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 organisms.

⛳️ Requirements

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

• At least 6 months of experience in travel monitoring.

• Preferred experience in therapeutic areas such as Oncology, Respiratory (COPD, asthma, nasal polyps, etc.), and Cardiovascular.

• Valid driver's license when applicable.

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

• Ability and willingness to travel 60–80%, including potential extended overnight stays.

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

• Must successfully complete a comprehensive background check, including drug screening.

• Demonstrated clinical monitoring skills.

• Knowledge of medical/therapeutic areas and medical terminology.

• Familiarity with ICH GCPs, applicable regulations, and procedural documents.

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

• Understanding of Risk-Based Monitoring concepts and processes.

• Effective oral and written communication skills.

• Customer-focused with good listening abilities, attention to detail, and capacity to identify underlying customer issues.

• Strong organizational and time management skills.

• Excellent interpersonal skills.

• Flexibility and adaptability.

• Ability to work independently or collaboratively in a team.

• Proficiency in Microsoft Office and capacity to learn relevant software.

• Strong English language and grammar skills.

• Presentation skills.

🏝️ Benefits

• Variable annual bonus based on performance results at the company, team, and/or individual level.

• National medical and dental coverage.

• National vision plan.

• Health incentive programs.

• Employee assistance and family support programs.

• Commuter benefits.

• Tuition reimbursement.

• A minimum of 120 hours of paid time off (PTO).

• 10 paid holidays each year.

• Paid parental leave: 3 weeks for bonding and 8 weeks for caregiver leave.

• Accident and life insurance.

• Short- and long-term disability coverage.

• 401(k) U.S. retirement savings plan.

• Employees’ Stock Purchase Plan (ESPP) with a discount on company stock.