Clinical Research Associate - Southeast USA

February 14

🐊 Florida – Remote

Although this job is listed in Florida, this company may be open to hiring remote in other states.

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔬 Research Analyst

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Zydus Therapeutics

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Dedicated To LifeZydus Therapeutics is a clinical stage, specialty-focused bio-pharmaceutical company focused on developing transformative treatments to transform lives, starting with rare and serious liver diseases and anemias.Our Purpose Is SimpleTo empower people with the freedom to live healthier and more fulfilling lives, by unlocking new possibilities in life sciences and providing quality healthcare solutions.

11 - 50 employees

📋 Description

• The CRA will be primarily responsible for managing and monitoring clinical trial activities at assigned study sites to ensure compliance with protocol, Good Clinical Practice (GCP) and applicable regulatory requirements. • The CRA will serve as the primary point of contact for investigators and site staff. • The CRA will collaborate closely with sites to complete required site visits (SQV, SIV, IMV,COV) and perform site management activities to ensure project timelines and deliverables are met. • The CRA must build and maintain strong collaborative relationships with investigative sites, as well as leverage strong knowledge of protocol to ensure subject safety, protocol compliance and validity of study data. • The CRA must be well organized, have high attention to detail skills, adapt quickly to changing priorities and propose reasonable solutions.

🎯 Requirements

• Bachelor’s Degree in scientific discipline or health care preferred • Minimum 5 years of onsite monitoring experience • In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., ICH – GCP guidelines. • Experience managing aspects of CRO functions is a plus • Ability to travel up to 80%, including overnight stays • Experience managing serious adverse events in collaboration with safety surveillance. Ensuring events are being properly followed to completion • Have effective organizational, communication and interpersonal skills • Ability to lead and conduct presentations • Coordinate, organize, and manage clinical study coordinator teleconferences on a routine basis, when necessary • Proficiency in clinical trial management systems (CTMS), EDC platforms, and Microsoft office suite • Strong analytical and problem-solving abilities. • Experience working in a fast paced, collaborative environment • Effective time and financial management skills • Prior experience in patient recruitment & retention strategies and site relationship management