Note: The job is a remote job and is open to candidates in USA. Avania is a clinical research organization supporting clinical trials in the medical technology field. The Senior Clinical Research Associate performs clinical trial oversight, protects human subjects, verifies trial data, ensures protocol and regulatory compliance, and supports investigational sites through monitoring, documentation, and study execution activities.
Responsibilities
- Interact with and guide study investigators and study coordinators in conducting clinical trials in accordance with study protocols. Member of a site Start-up Team for assigned projects
- Monitor site’s completion of action items between visits and help prepare for audits and inspections; conduct and write accurate visit reports in accordance with SOPs and GCP (SQV, SIV, IMV, COV)
- Ensure data entered on the CRFs is timely, accurate and verified. Collaborate with analytical services to obtain clean database, resolve queries and conduct or participate in data reviews (both internally and with sponsor), identifying and communicating trends or erroneous data
- Participate in internal TMF reviews, as needed
- Develop and maintain trackers, such as visit reports trackers, site trackers, recruitment and enrollment trackers
- Review and write informed consent forms. Review of protocols, investigator brochures on compliance with applicable regulations and CRFs in development. Prepare clinical trial agreements and present to site and study sponsor
- Review regulatory compliance for study documents and protocols
- May act as a Clinical Lead, overseeing clinical trial activities at investigational sites (will require travel to investigational sites)
Skills
- B.A./B.S. or equivalent experience in a (para)medical, scientific or health related discipline or related work experience
- Medical Device Experience Required
- Minimum 3-7 years of relevant CRA work experience, with extensive medical device monitoring experience
- Tracker and Start-up experience (with good spreadsheet or similar skills)
- Ability to understand basic and complex medical details
- GCP-ICH-E6, FDA regulations and ISO 14155, 13485 and 9001 knowledge where applicable; knowledge of/ability to learn regulations and guidelines on medical devices and clinical trials
- Ability to travel up to 75% domestically and internationally
- Strong communicator with excellent presentation skills; able to build rapport with site personnel
- Region Preference for East / Central or Mid west
- Therapeutic Preference: Medical Device / Urology / Cardiovascular / Oncology
- Experience as a Clinical Lead helpful
Benefits
- Annual Performance related bonus
- Benefits
- 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
- Hybrid and fully remote work opportunities
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