Key Skills

Job Description

Avania is hiring - Clinical Lead (Lead Clinical Research Associate) As Clinical Lead, you will work with a sponsor companies in the monitoring of medical device and MedTech studies with an emphasis placed on ensuring the highest ethical and clinical standards. You will 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 Clinical Lead (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 Clinical Lead 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 Clinical Lead 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 of 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 The opportunity to work in an innovative, fast-growing and rewarding industry 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 Competitive compensation and benefits package (details shared during the interview process) Avania - MedTech's trusted Champion

Core Responsibilities

Lead and coordinate study-specific monitoring activities, training, monitoring tools, and team communications while ensuring visits and documentation meet quality and timeline expectations. Support CRAs through mentoring, co-visits, report reviews, and issue escalation, and collaborate with the Project Manager and clients to meet study objectives.

Requirements

Requires an RN or a bachelor's degree in a science, life science, engineering, or health-related field, plus at least four years of monitoring experience. Candidates should know clinical research regulations and standards, have experience mentoring and training CRAs, and demonstrate strong organizational, communication, writing, and problem-solving skills.

Benefits

• Competitive Compensation
• Benefits Package
• Training and Development Opportunities
• Career Advancement Opportunities