Lead Clinical Research Associate

Avania is hiring - Clinical Trials Lead (Lead Clinical Research Associate!)

As Clinical Trials Lead (Lead Clinical Research Associate), you will work with a sponsoring company in the monitoring of medical device and MedTech studies with an emphasis placed on ensuring the highest ethical and clinical standards.

You will also assume a key role in the monitoring team by supervising project-specific monitoring activities, coordinating project-specific training, and interacting with our clients. Avania's Lead Clinical Research Associate (CTL / Lead CRA) acts as the primary contact for study questions from the monitoring team, organizes team training and study updates, and generates necessary monitoring tools. You will ensure monitoring visits are being conducted as needed and tasks are being completed in an appropriate and timely manner. Further, you will complete peer review of required study documentation to ensure these are accurate, complete, and of high quality. You will also represent Avania on study conference calls and / or meetings.

The Lead CRA will collaborate with the Project Manager to ensure study objectives are met. You may also handle CRA study activities as needed. Finally, you will provide CRA support, including such activities as assisting Clinical Research Associates with difficult or challenging situations or corrective actions, conducting co-visits and providing feedback, reviewing monitoring reports, and similar work.

This position requires travel approximately 25 – 30% of the time.

Candidates who offer a combination of the skills, knowledge and experience listed below are encouraged to apply for Avania's Lead CRA opportunity. With our continued growth we are hiring talent to join us on our journey and grow with us.

We seek -

• RN or BA / BS degree in a science / life science, engineering or health-related field plus a minimum 4 years monitoring experience
• Knowledge of medical and clinical research terminology; knowledge of EU / US federal regulations related to clinical research studies, ICH / GCP Guidelines and ISO 14155; ability to acquire knowledge across multiple therapeutic areas
• Experience as mentor and trainer for new CRAs
• Ability to complete assessment, initiation, periodic, and close-out monitoring visits to sites, including preparation and post-visit documentation
• Ability to work concurrently on multiple protocols and procedures; organizational, time management skills and problem-solving abilities
• Excellent communication skills; demonstrated professional writing proficiency
• Computer proficiency (Excel especially helpful)
• Experience generating project-specific training presentations and coordinating necessary training
• Good relationship building skills - demonstrates a willingness to work in and values a team environment; ability to work with clients and site personnel
• Ability to generate monitoring tools; experience generating and giving professional presentations
• Capable of fielding questions from the monitoring teams across projects and escalating issues to the Sponsor as necessary
• Achievement of / working towards clinical research certification helpful

We offer -

We look forward to receiving your application!

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