Kelly Services Clinical Research Associate in Emeryville, California
Sr. Clinical Research Associate, Emeryville, CA
Prepare all manner of documents related to the clinical trial process
Participate in the selection of clinical study sites.
Activate and manage clinical study sites throughout the clinical trial process
Assist with selection of CROs and other contract vendors and provide oversight to ensure outsourced tasks are performed in accordance with GCP and contract specifications.
Negotiate and prepare financial documents e.g. contracts, budget proposals, and coordinate with legal department for confidentiality and indemnification agreements, insurance, etc.
Monitor clinical sites, and/or provide oversight of contract monitoring, including qualification, initiation, interim monitoring and close-out activities, to assure studies are conducted in compliance with the study protocol, Standard Operating Procedures, Good Clinical Practice and applicable federal, state and local requirements.
Assist with the review and evaluation of moderate to complex clinical data.
Attend project team meetings as GCO representative, as required
Develop and maintain effective working relationships with other functional areas and cross-cultural team members to facilitate clinical trials research.
Assist with writing and/or review of clinical sections of regulatory submissions to FDA e.g. INDs, NDAs, Annual Reports, Pre-meeting Packages, Clinical Study Reports etc. for assigned project s , as requested.
Provide support to management of budgets, schedules, and resource requirements for assigned projects.
Prepare and/or present written and oral presentations regarding clinical trial progress/results to GCO Department meetings.
Support non-project initiatives as GCO representative e.g. CTMS or other technology initiatives as requested by management.
Author or review clinical standard operating procedures as requested by management.
Maintain up to date operational knowledge of Good Clinical Practices, regulations, and guidance documents and industry trends/best practices.
Suggest courses/seminars to attend to further develop professional expertise in clinical research.
A minimum of five 5 years of Clinical Research experience, preferably in Ophthalmology, with a BS degree in a scientific discipline, RN, BSN degree or equivalent.
An MS, PharmD and/or PhD may be considered with less than five 5 years of related Clinical Research experience.
Strong verbal and written communication skills and good interpersonal/group skills.
Must be able to communicate information between regions and with senior level management
Leadership and management skills to effectively assist with management of CROs and other vendors
Must demonstrate tact and ability to positively influence others in interpersonal and group interactions. Significant knowledge of FDA and ICH regulatory requirements
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—
providing you with opportunities to work on today’s most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help
advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000
scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
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Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.