[Remote] Sr. Clinical Research Associate / Field Clinical Specialist

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.ResponsibilitiesInteract 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 projectsMonitor 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 dataParticipate in internal TMF reviews, as neededDevelop and maintain trackers, such as visit reports trackers, site trackers, recruitment and enrollment trackersReview 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 sponsorReview regulatory compliance for study documents and protocolsMay act as a Clinical Lead, overseeing clinical trial activities at investigational sites (will require travel to investigational sites)SkillsB.A./B.S. or equivalent experience in a (para)medical, scientific or health related discipline or related work experienceRegion Preference for Central / Mid west / West CoastMedical Device Experience RequiredTherapeutic Preference: Medical Device / Urology / Cardiovascular / OncologyMinimum 3-7 years of relevant CRA work experience, with extensive medical device monitoring experience and nursing qualificationsTracker and Start-up experience (with good spreadsheet or similar skills)Ability to understand basic and complex medical detailsGCP-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 trialsAbility to travel up to 75% domestically and internationallyStrong communicator with excellent presentation skills; able to build rapport with site personnelExperience as a Clinical Lead helpfulBenefitsAdditional annual performance related bonusBenefitsTraining and other development opportunitiesCompetitive compensation and benefits package (details shared during the interview process)Hybrid and fully remote work opportunitiesCompany OverviewAvania 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/.