In House Principal Clinical Research Associate

Elixir Medical Corporation; United States; On-site; USD 70,000 - 100,000; Full time

Job summary

A medical device company is seeking an experienced Clinical Research Associate to support clinical trials across all phases. The role involves developing study documentation, ensuring compliance with regulations, and providing mentorship to in-house CRAs. Ideal candidates will have over 7 years of experience in the field, strong knowledge of medical terminology, and excellent communication skills. This position is based in the United States, with minimal travel required to headquarters.

Qualifications

• 7+ years as a Clinical Research Associate in clinical trials.
• Lead in-house clinical contact for projects.
• Strong knowledge of FDA/MDR regulations and ICH GCP guidelines.

Responsibilities

• Develop study documentation and training materials.
• In-house monitoring of study processes.
• Support audit readiness and clinical staff.

Skills

Clinical Research

Medical Terminology

Communication Skills

Auditing Skills

Microsoft Office

Electronic Data Capture (EDC)

Education

Bachelor’s degree in life sciences

Job description

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