Clinical Research Associate

Responsibilities:

Conduct single or multi-center medical device clinical studies.

Perform study site visits (SQV, SIV, IMV, COV), generate monitoring trip reports, and track resolution of action items.

Participate in study start up activities.

Responsible for shipping study devices and supplies to clinical sites and performing study device accountability.

Manage clinical monitoring activities and overall site management ensuring compliance to the Study Protocol, Good Clinical Practices (GCPs), ICH guidelines, Federal Regulations, department procedures and applicable regulatory requirements.

Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), conducting User Acceptance Testing (UAT), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions.

Ensures quality delivery of study deliverables within agreed budgets and timelines.

Participate in the interim and final reviews of study data in preparation of regulatory submissions.

May interact with RA/QA in responding to audits and FDA inquiries.

Requirements:

BS degree in life sciences or equivalent with minimum 3years of related experience, or MS degree in life sciences or equivalent with minimum 1 years of experience, or PhD with 1+ years of experience.

Must have 3+ years of relevant experience in site monitoring, clinical project management, clinical trial practices and regulations.

Experience in conducting medical device and/or in-vitro diagnostics studies. Pharmaceutical background may also be considered.

Demonstrated excellence in teamwork, shared mindset for success, stellar interpersonal and communication skills including building rapport with team members, peers, and management.

Must have a demonstrated ability to solve problems with innovative solutions along with strong project management and organizational skills to deliver projects on time and on budget.

Able to manage numerous projects/conflicting priorities, and to be flexible when priorities change. .

Working knowledge of GCP, Clinical and Regulatory Affairs.