FSP CRA I & CRA II - Respiratory & Cardiovascular - Southeast region

About the role

We are seeking a Clinical Research Associate (Level II) to join our dynamic team. This position offers the opportunity to support the top 50 pharmaceutical companies and over 750 biotech firms in conducting clinical trials globally.

Responsibilities

• Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation.
• Manage procedures and guidelines from different sponsors and/or monitoring environments (FSO, FSP, Government, etc.).
• Act as a site processes specialist to ensure the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs.
• Ensure audit readiness and develop collaborative relationships with investigational sites.
• Detailed tasks and responsibilities are outlined in the task matrix.

Requirements

• Bachelor's degree in a life science related field or Registered Nursing certification with relevant formal academic/vocational qualification.
• Previous experience in travel monitoring for at least 6 months.
• Preferred therapeutic areas: Respiratory (COPD, asthma, nasal polyps, etc.) and 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.

Qualifications

• 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 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.
• Good organizational and time management skills.
• Effective interpersonal skills.
• Attention to detail.
• Ability to remain flexible and adaptable in a wide range of scenarios.
• 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/lab/clinical/home office environment with exposure to electrical office equipment. Frequent drives to site locations. Frequent travel, generally 60-80%, but more for some individuals. Extended overnight stays may also be required. 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.