[Remote] In House Principal Clinical Research Associate
Note: The job is a remote job and is open to candidates in USA. Elixir Medical Corporation is seeking an In House Principal Clinical Research Associate to oversee 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 all 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, track 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 all 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 Clinical trials of all phases
• Ability to be primary / lead 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 Microsoft Office suite of applications (Word, Excel and PowerPoint)
• Prior experience with Electronic Data Capture (EDC) systems
• Minimal Travel to headquarters on an ad-hoc basis
• Medical device trial experience strongly preferred
• Bachelor's degree or higher in a life sciences discipline preferred
• CCRA preferred
Company Overview
• 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.
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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 all 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, track 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 all 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 Clinical trials of all phases
• Ability to be primary / lead 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 Microsoft Office suite of applications (Word, Excel and PowerPoint)
• Prior experience with Electronic Data Capture (EDC) systems
• Minimal Travel to headquarters on an ad-hoc basis
• Medical device trial experience strongly preferred
• Bachelor's degree or higher in a life sciences discipline preferred
• CCRA preferred
Company Overview
• 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