Kelly is currently seeking a Sr. Clinical Research Associate for a long-term engagement with one of our Global Medical Device clients in the Irvine, CA area. This position will be able to work remotely and be home-based.
This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
Monitors and reports on the conduct of simple to complex clinical research studies required to enter new products into the marketplace or to expand product claims, in compliance with state and federal regulations, industry standards and corporate policies. Effectively manages multiple clinical sites to assure accurate and timely initiation, enrollment, conduct and completion for assigned clinical trials.
Compliance with applicable Corporate and Divisional policies and procedures, guidelines, standards and regulations.
Serving as primary contact for investigative site communication for each assigned site.
Collaborating with investigative sites to ensure completion and appropriate submission of all required clinical trial documents prior to site initiation.
Coordinating Institutional Review Board/ Ethics Committee (IRB/EC) approvals, as appropriate.
Training investigative site personnel to ensure compliance with study requirements and GCP, including, but not limited to the protocol, IRB/EC instructions, industry guidelines, international standards and local and national regulations.
Evaluating actual enrollment against assigned targets and working with assigned sites to meet, and whenever feasible, exceed enrollment targets.
Assessing case report forms (CRFs) for trends in safety, effectiveness, and adherence to protocol.
Performing on-site monitoring activities for assigned investigative sites in compliance with the approved monitoring plan and SOPs, with specific tasks to include:
Ensuring that final CRFs are accurate and complete by verifying against source documentation, as assigned.
Ensuring that all clinical trial documentation is properly reviewed, approved and filed within the Trial Master File and is accessible to investigative site personnel.
Ensuring investigational product and, as applicable clinical supplies accountability, handling and documentation are sufficient to continue, accurate, updated and appropriately delegated.
Preparing, submitting and filing of quality monitoring visit reports and associated follow-up letters in a timely manner.
Providing regular updates to the Investigator of assigned investigative sites, Study Manager and/or Lead CRA with respect to study conduct and compliance
Monitoring overall progress of clinical trials by regularly attending project and/or clinical trial team meetings, reviewing team communications and sharing pertinent information with assigned investigative sites, Study Managers, Lead CRAs, CRAs and other clinical trial team members.
Maintaining audit/inspection readiness at assigned sites throughout the conduct and upon closure of clinical trials at assigned investigative sites.
Supporting study payment activities or accruals, as assigned.
Ensuring all equipment/supplies provided to investigative sites is appropriately reported to Study Manager and/or Lead CRA.
Minimum education required for competent performance:
Minimum experience (number of month/years and type of work experience beyond formal education) required for competent performance:
3+ years of clinical research experience with independent field monitoring experience.
Medical Device industry experience preferred, but not required.
Knowledge of ophthalmology required.
Knowledge and understanding of application of GCP, specifically as it applies to investigative site conduct of clinical trials.
Ability to successfully manage competing priorities and adapt quickly to changing priorities.
Ability to problem-solve.
Effective communication via written, verbal and listening skills, with ability to effectively deliver training or informational presentations at internal or external meetings desired.
Proficiency with MS Word, Excel and PowerPoint.
Proven ability to operate in a home office environment with flexibility to travel and report to corporate offices, as appropriate.
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At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
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