Principal Clinical Research Associate (In-House Principal CRA)

ELIXIR MEDICAL CORPORATION; Milpitas (CA); On-site; USD 125,000 - 135,000; Full time

Job summary

ELIXIR MEDICAL CORPORATION seeks an experienced Principal Clinical Research Associate for in-house oversight of trials and regulatory compliance in Milpitas, CA. You will lead documentation, in-house monitoring, and vendor training, ensuring audit readiness and rigorous data management.

Qualifications include 7+ years as an CRA, strong knowledge of FDA MDR and ICH GCP, and proficiency with MS Office and EDC systems. Some travel may be required.

Qualifications

• 7+ years as a Clinical Research Associate supporting multicenter trials.
• Ability to be primary/lead in-house clinical contact for a project.
• Experience with FDA MDR regulations and ICH GCP guidelines.

Responsibilities

• Develop site and study documentation such as training materials, protocols, plans, and regulatory submissions.
• Perform in-house monitoring of CRFs and regulatory files.
• Support audit readiness and preparations for clinical staff.
• Review processes for GDP, GCP, and regulatory compliance.
• Maintain documentation of all clinical activities and file management.
• Monitor site and subject enrollment, milestones, and trial invoices.
• Prepare materials for study initiations and investigator meetings.
• Prepare vendor training materials and coordinate meetings.
• Support inventory administration including shipping/receiving.
• Support data management activities and EDC-related tasks.
• Mentor other in-house CRAs as assigned.

Skills

Leadership/primary lead

FDA MDR knowledge

ICH GCP guidelines

Auditing/self-auditing

Verbal & written communication

Multitasking

MS Office proficiency

EDC systems

Education

Bachelor’s degree or higher in life sciences

CCRA preferred

Tools

Microsoft Office (Word, Excel, PowerPoint)

EDC systems

Job description

Principal Clinical Research Associate (In-House Principal CRA)

Major Duties and Responsibilities

Responsibilities will include, but not be limited to:

• 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

Qualifications

Experience

• 7+ years in the role of Clinical Research Associate supporting Clinical trials of all phases, medical device trial experience strongly preferred
• 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

Education Requirements

• Bachelor’s degree or higher in a life sciences discipline preferred
• CCRA preferred

The salary range is $125K to $135K based on factors including geographic location, experience, skills, etc.

Fields marked with an asterisk (*) are required.

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