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Avania · 4 months ago

Sr. Clinical Research Associate / Field Clinical Specialist

United States

Full-time

Hybrid

Mid, Senior Level

3+ years exp

Avania is hiring Senior Clinical Research Associates (Sr CRAs) / Field Clinical Specialist (FCS). The Sr CRA performs clinical trial oversight, ensuring the rights and well-being of human subjects are protected and that trial data is accurate and verifiable. This role involves guiding study investigators, monitoring compliance, and participating in data reviews, among other responsibilities.

Health CareMedical Device

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

Medical Device ExperienceGCP-ICH-E6 KnowledgeClinical Trial OversightTrackerStart-up ExperienceRegulatory Compliance KnowledgeProactive AttitudePrioritize TasksCommunication SkillsPresentation SkillsTeam Collaboration

Required

B.A./B.S. or equivalent experience in a (para)medical, scientific or health related discipline or related work experience

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

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