[Remote] Clinical Lead (Lead CRA)

Note: The job is a remote job and is open to candidates in USA. Avania is hiring a Clinical Lead to support a sponsoring company’s medical device and MedTech studies. The role leads project-specific monitoring activities, training, documentation review, and CRA support while collaborating with the Project Manager to meet study objectives.

Responsibilities

• As Clinical 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

Skills

• 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 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

Benefits

• 10% bonus potential
• 4 weeks PTO
• A dynamic and enthusiastic global team that fosters collaboration and the opportunity to work with experts across many specialties
• Exchange of knowledge and ideas to help employees grow and advance their careers, backed with training and other development opportunities
• Some roles offer the opportunities for travel
• Ask us about our hybrid and fully remote work opportunities

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