Kelly Services Clinical Research Associate in Emeryville, California

Sr. Clinical Research Associate, Emeryville, CA

Responsibilities:

  • 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.

Requirements:

  • 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

with us on Facebook , LinkedIn and Twitter .

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.