Clinical Research Associate II

Avania is hiring Clinical Research Associate II (CRA II) Avania’s ClinOps Team establishes, maintains and supports clinical trials; as a key member of the team, our CRA II performs clinical trial oversight for the trials, verifying that the rights and well-being of human subjects are protected, and that reported trial data are accurate, complete, and verifiable (from source documents). Partnering closely with our Trial sites, Avania's CRA II ensures that the conduct of the trial follows approved protocols/amendment(s), with ISO14155 or ICH-GCP, and with applicable regulatory requirements.Our CRA II role includes the following key activitiesInteract 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.Candidates who offer a combination of the skills, knowledge and experience listed below are encouraged to apply. With our continued growth we are hiring talent to join us on our journey and grow with us.CRA II require skills in planning and preparation; sourcing and collecting information; prioritizing tasks and actions; and displaying a proactive attitude to assist in project planning and study execution.We seek -B.A./B.S. or equivalent experience in a (para)medical, scientific or health related discipline or related work experience.Minimum 3-5 years of relevant CRA work experience, ideally with cardiology Class III 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.Experience as a Clinical Lead helpfulStrong communicator with excellent presentation skills; able to build rapport with site personnelWe offer -The opportunity to work in an innovative, fast-growing and rewarding industryA dynamic and enthusiastic global team that fosters collaboration and the opportunity to work with experts across many specialtiesExchange of knowledge and ideas to help employees grow and advance their careers, backed with training and other development opportunitiesCompetitive compensation and benefits package (details shared during the interview process)Some roles offer the opportunities for travelAsk us about our hybrid and fully remote work opportunitiesWe look forward to receiving your application!When you need to advance your career, it takes Avania!