- 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.
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Description
Job Description
Job DescriptionThe Clinical Research Associate position is responsible to support and execute clinical project plans to identify and complete clinical trial milestones with accountability for successful completion of all project deliverables for clinical trials in accordance with GCP, all applicable regulations, and SOPs. In addition, they will support analysis of trial performance for opportunities for improvement. Identify and communicate study risks; recommend mitigation strategies and alternative solutions; and upon leadership alignment lead in the implementation of corrective actions in collaboration with cross functional and/or matrix teams.
ROLES AND RESPONSIBILITIES
REQUIRED QUALIFICATIONS
PREFERRED QUALIFICATIONS
Located in Burlingame, CA, near the Millbrae Caltrain and BART Station
Our job titles may span more than one career level. The starting base salary for this role is between $90,000 and $110,000 depending on experience. The actual base pay is dependent upon many factors, such as: education, training, transferable skills, work experience, business needs, and location. The base pay range is subject to change and may be modified in the future. This role may also be eligible for equity, benefits and 401(K) with matching.
