Contract Senior Clinical Research Associate

The Contract Senior Clinical Research Associate role is based in the United States and involves managing and overseeing clinical trials across pharmaceutical, biotech, and medical device studies. Key responsibilities include:

1. Conducting clinical monitoring activities including qualification, initiation, interim, and close-out visits across assigned study sites.
2. Ensuring clinical trials are executed in compliance with study protocols, SOPs, ICH-GCP guidelines, and regulatory requirements.
3. Training and supporting site personnel on protocol requirements, therapeutic areas, source documentation, and CRF completion.
4. Maintaining complete and audit-ready study documentation and trial master files.
5. Managing data queries, resolving discrepancies, and providing guidance to junior CRAs.

Requirements include:

• Bachelor’s degree, RN qualification, or advanced degree in biological sciences or related field, or equivalent combination of education and CRA experience.
• Proven experience as a Clinical Research Associate with demonstrated career progression.
• Strong knowledge of ICH-GCP guidelines, FDA regulations, and clinical trial processes.
• Experience conducting site monitoring visits across all phases of clinical trials.
• Familiarity with pharmaceutical, biotech, or medical device clinical research environments.
• Excellent organizational skills with the ability to manage multiple studies and priorities simultaneously.
• Strong communication and interpersonal skills for effective collaboration with sites and cross-functional teams.
• High attention to detail and strong problem-solving abilities.
• Proficiency in Microsoft Office tools (Word, Excel, PowerPoint).
• Ability and willingness to travel up to approximately 65%, including short-notice travel.
• Ability to work independently in a fast-paced, changing environment.

Benefits include:

• Competitive contract-based compensation (aligned with experience and market standards).
• Opportunity to work across diverse clinical trials in pharmaceutical, biotech, and medical device sectors.
• Significant travel exposure across multiple therapeutic areas and study sites.
• A collaborative and mission-driven environment focused on advancing global health outcomes.
• Exposure to high-quality clinical research processes aligned with industry-leading standards (GCP/FDA).
• Opportunity to strengthen expertise in clinical monitoring and regulatory compliance.
• Work within a supportive structure that values professional growth and accountability.