Note: The job is a remote job and is open to candidates in USA. Avania is hiring Senior Clinical Research Associates (Sr CRAs) / Field Clinical Specialists (FCS) to support clinical trials. The role involves oversight of clinical trials, ensuring compliance with protocols and regulatory requirements, and interacting with study investigators and coordinators.
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
- 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
- Experience as a Clinical Lead helpful
Benefits
- Additional annual performance related bonus
- Benefits
- Training and other development opportunities
- Competitive compensation and benefits package (details shared during the interview process)
- Hybrid and fully remote work opportunities
Company Overview
Avania is a full-service contract research organization focused on the management of clinical studies for medical devices, IVDs, biologics. It was founded in 1988, and is headquartered in Marlborough, Massachusetts, USA, with a workforce of 201-500 employees. Its website is https://www.avaniaclinical.com/.