Clinical Research Associate

Description:

ORCA Trial LLC is a forward-thinking clinical research organization dedicated to connecting research sites with global Sponsors and CROs. As a trusted partner in the clinical trial ecosystem, we prioritize precision, innovation, and collaboration. Our inclusive and diverse team thrives on making a meaningful impact in healthcare.

The Opportunity

We’re seeking a Clinical Research Associate (CRA) to play a role in ensuring the successful execution of clinical trials. If you’re detail-oriented, passionate about clinical research, and eager to contribute to groundbreaking studies, we want you on our team!

What You’ll Do

✔ Monitor Clinical Trials: Conduct site visits (remote, on-site, or hybrid) to ensure compliance with protocols, GCP, and regulatory requirements.

✔ Support Site Management: Assist research sites with study start-up, documentation, and ongoing trial coordination.

✔ Liaise with Stakeholders: Serve as the primary point of contact between sites, Sponsors, and CROs to resolve issues and streamline communication.

✔ Regulatory Compliance: Track essential documents (e.g., investigator CVs, FDA 1572s, IRB approvals) and maintain audit-ready trial master files (TMFs).

✔ Problem-Solving: Identify and mitigate risks to study timelines, data integrity, and participant safety.

What We’re Looking For

🎓 Education: Bachelor’s degree in administration, pharmacy, or a related field (advanced degrees/certifications a plus).

💼 Experience: Prior experience as a CRA, CRC, or in clinical trial monitoring is preferred. Familiarity with ICH-GCP, FDA/EMA regulations, and clinical trial protocols.

New graduates with strong academic backgrounds and internships in clinical research are encouraged to apply!

🔑 Key Skills:

• Exceptional organizational abilities.
• Strong written/verbal communication and interpersonal skills.
• Proficiency in Microsoft Office, using AI for work and Email Communication