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
- Supports department activities as required
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.