We are looking for a Freelance, Part-Time CRA located on the U.S. East Coast to support and strengthen our Clinical Operations team.
Job Requirements:
- Bachelor’s degree required – preferred qualification in life sciences or medical sciences
- Minimum 3 years of experience of onsite monitoring activities
- Profound knowledge of clinical research processes and medical terminology
- Expert knowledge of ICH GCP, and international and local regulatory requirements
- Passion for clinical research
- English language proficiency of minimum level C1 (ref. CEFR) – fluent in written and spoken English
- Driving license B and ability to travel
Job Responsibilities:
- You would be primarily responsible for monitoring clinical trials and
- Ensuring that clinical trial is conducted, recorded, and reported in accordance with all applicable international and local regulations and guidelines, good practices, SOPs and Clinical Trial Protocol
- Ensuring data quality and integrity meet acceptable clinical standards
- Guaranteeing the rights and safety of patients involved in a study are protected
- Performing and coordinating all aspects of the clinical monitoring and site management process
- Conducting remote and on-site visits to assess protocol and regulatory compliance and managing required documentation
- Developing collaborative relationships with investigational sites, act as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects rights, well-being, and data reliability; and you would ensure audit readiness.
- Serving as facilitator of Clinical Trial conduct in respective area in terms of identifying qualified sites and investigators, facilitating communication between sponsor and regulatory authorities and trial sites.
What We Offer:
- Competitive salary
- Friendly environment in a privately owned international company
You can apply via the link or send a CV directly to:
* SanaClis is an equal employment opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin, ancestry, age, disability, marital status, pregnancy, protected veteran status, order of protection status, protected genetic information, or any other characteristic protected by law.