Kelly Services Clinical Trials Management Associate in Foster City, California

Kelly Scientific Resources is a specialty service of Kelly Services®. As the world's largest provider of HR solutions to the scientific community, Kelly Scientific Resources is focused exclusively on placing skilled scientific professionals in contract, contract-to-hire, and full-time science jobs across a full spectrum of related industries and disciplines. Our scientists contribute to the research and development of therapeutics that change the lives of those affected with disease. We have an exciting contract opportunity in the Foster City area for a Clinical Trials Management Associate to join a leading biotherapeutics client.

Clinical Trials Management Associate II

Description:

  • Must meet all requirements for Clinical Research Associate position and have demonstrated proficiency in all relevant areas.

  • With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required.

  • Assures site compliance with the routine protocol and regulatory requirements and quality of data.

  • Assists in the setting and updating of study timelines.

  • Assists in CRO or vendor selection.

  • With guidance from supervisor coordinates CROs or vendors.

  • Drafts and coordinates review of protocols, informed consents, case report forms, and monitoring plans and other study related documents.

  • Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.

  • Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams.

  • May participate in abstract presentations, oral presentations and manuscript development. Interfaces with individuals in other functional areas to address routine study issues.

  • May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants.

  • Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives.

  • Travel is required.

Requirements:

  • Excellent verbal, written, interpersonal and presentation skills are required.

  • Working knowledge and experience with Word, PowerPoint and Excel.

  • Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.

  • Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.

  • Ability to develop tools and processes that increase measured efficiencies of the project.

  • Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.

  • Must have a general understanding of functional issues and routine project goals from an organizational perspective.

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.