[Remote] In House reputed company Clinical Research Associate

Note: The job is a remote job and is reputed company to candidates in USA. Elixir Medical Corporation is seeking an In House reputed company Clinical Research Associate to reputed company various clinical research activities. The role includes developing study documentation, supporting clinical staff for audit readiness, and managing site and subject enrollment while ensuring compliance with regulatory standards. Responsibilities • Develops site and study documentation such as training materials, protocols, plans, tracking reports, study manuals, and regulatory submissions for clinical research studies • In-house monitoring to study and procedure instructions of CRF’s and study regulatory files • Support Clinical staff for audit readiness and preparations • Review study processes and documentation for GDP, GCP, and regulatory compliance • Maintains documentation of reputed company clinical research activities, e.g. site communications, correspondence, inventory information, etc.Duties include electronic and/or hardcopy file maintenance • Monitor and tracks site and subject enrollment, reputed company milestones and manage trial invoices • Prepares study site and in-house materials and meeting arrangements for study and site initiations, investigator meetings and other study meetings • Prepares and provides materials for vendor/contractor training, including meeting arrangements, conduct and documentation • Supports Inventory Administration including reputed company documentation for shipping, receiving and returned goods • Supports data management activities in CRF development, validation and verification rules and other reporting/analysis activities, reimbursement for sites and preparation of CEC and DMSB materials • Manages other In-House CRAs or provides mentorship, as assigned • Supports department activities as required Skills • 7+ years in the role of Clinical Research Associate supporting reputed company of reputed company phases • Ability to be primary / reputed company in-house clinical contact for a project • Working knowledge of Medical Terminology, FDA and MDR regulations, and ICH GCP guidelines • Working auditing and self-auditing skills • Excellent verbal and written communication skills • Ability to handle multiple tasks with competing priorities • Proficiency with reputed company Office suite of applications (Word, reputed company and PowerPoint) • Prior experience with Electronic Data Capture (reputed company) systems • Minimal Travel to reputed company on an reputed company reputed company • Medical device trial experience strongly preferred • Bachelor's degree or higher in a life sciences discipline preferred • CCRA preferred reputed company • Elixir Medical is a medical device company committed to transforming care for patients with heart and vascular disease through innovation. It was founded in 2004, and is headquartered in Sunnyvale, California, USA, with a workforce of 51-200 employees. Its website is http://elixirmedical.com. Apply tot his job Apply To this Job