Avania · 1 month ago
Sr. Clinical Research Associate / Field Clinical Specialist
United States
Full-time
Remote
Senior Level
3+ years expAvania is a company focused on clinical trials, and they are seeking Senior Clinical Research Associates (Sr CRAs) / Field Clinical Specialists (FCS) to join their ClinOps Team. The role involves overseeing clinical trials, ensuring compliance with protocols and regulations, and collaborating with trial sites to protect the rights and well-being of human subjects.
BiotechnologyHealthcareLife ScienceMedical DeviceClinical TrialsHealth Care
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)
Qualification
Required
B.A./B.S. or equivalent experience in a (para)medical, scientific or health related discipline or related work experience
Region Preference for Central / Mid west / West Coast
Medical Device Experience Required
Therapeutic Preference: Medical Device / Urology / Cardiovascular / Oncology
Minimum 3-7 years of relevant CRA work experience, with extensive medical device monitoring experience and nursing qualifications
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
Preferred
Experience as a Clinical Lead helpful
Benefits
Additional 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 (details shared during the interview process)
Some roles offer the opportunities for travel
Ask us about our hybrid and fully remote work opportunities
Company
Avania
Avania is the leading global MedTech-focused CRO, integrating regulatory strategy, clinical development, and market access with confidence.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
Kester Capital
2022-06-20Acquired
2016-06-01Private Equity
Leadership Team
Jason Monteleone
President & Chief Executive Officer
Angela Johnson
SVP Advisory Services
Recent News
2025-09-06
Business Wire India
2025-04-18
Company data provided by crunchbase