Clinical Research Associate (will consider Sr. Level candidates)
Russell Solutions Group
- Burlingame, CA
- $90,000-110,000 per year
- Permanent
- Full-time
- Lead project document organization and reconciliation and setting up clinical trial files (including Clinical Trial Master File).
- Assist with the development, approval, and distribution of study-related documents including Case Report Forms (CRF’s), study protocols, study manuals, and other study tools to investigational sites and review committees.
- Assist with the development, negotiation, and execution of the site contract, budget, and payment plan.
- Draft informed consents with supervision.
- Provide oversight on device accountability, inventory, and distribution, device complaint/malfunction processing and tracking. Based upon Clinical requirements, monitor ongoing compliance to study protocols and site adherence to global regulatory guidelines, including safety reporting.
- Prepare and participate in presentation of protocols and other study conduct requirements at study initiations including training at investigational sites when needed.
- Data coordination- actively participates in the development and testing of case report forms, study reports, and study databases based on protocol requirements.
- Ensures timely and quality completion of data forms, verifies study data, and generates, manages, and resolves data discrepancies.
- Support assignment for study specific training and rosters
- Document coordination - creates and manages the clinical study files and oversees the organization and distribution of clinical study documents.
- Assists with periodic audits of clinical study files for completeness and accuracy.
- Provide project/program coordination and support.
- Maintains study-specific correspondence and other required documentation.
- Assists/coordinates in the organization and distribution of clinical study documentation
- Assist in tracking study activity, such as start-up progress by ensuring receipt of proper study documentation, agreements, and site approvals.
- Assist in the coordination of meetings and meeting logistics.
- Create and distribute newsletters and communications to sites.
- Support, monitor, and analyze daily projects and contracts using Excel, Power Point, EGNYTE, SharePoint, and shared network drive.
- Create, run, and monitor metrics and maintenance reports on an ongoing basis.
- Bachelors Degree in life sciences or a licensed healthcare professional such as RN or equivalent experience.
- Minimum of 5 years industry experience in related role (site management, study coordinator, in-house CRA)
- Excellent written and verbal communication, presentation, relationship management and negotiation skills.
- Demonstrated ability to develop clinician, research personnel, peer, cross functional and cross business unit relationships to maximize best practice sharing and optimize processes.
- Proven successful project management skills that drive continuous evolution while maintaining strict attention to detail.
- Ability to interact professionally and effectively with clinicians, hospital research personnel and internally with all organizational levels including proactively escalate issues to appropriate levels of management in the organization.
- Excellent problem-solving, organizational, analytical, and critical thinking skills including high discretion/judgment in decision making.
- Ability to work and excel within a fast-paced, dynamic, and continuously changing work environment while demonstrating a sense of urgency.
- Ability to travel frequently to clinical sites.
- Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred.
- Startup experience (jumping in and doing what needs to be done).
- Experience working with medical devices associated with cardio and peripheral vascular indications.