Kelly Services CR03 - Clinical Documentation Specialist in Emeryville, 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 Emeryville area for a Clinical Documentation Specialist to join a leading biotherapeutics client.

SUMMARY:

The Clinical Supply Specialist is responsible for supporting multiple clinical programs working closely with the Clinical Supplies project leads. The selected candidate will independently coordinate clinical supply activities for clinical studies in support of development programs. The activities include review of clinical study protocols, design of clinical labels, preparation of packaging and labeling requests, management of depot and site shipments, monitoring study drug inventory levels, and assist in supply planning and forecasting.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Assist with planning and execution of clinical packaging projects, including oversight of CMO scheduling, production of labels, and packaging of clinical trial supplies

  • Review clinical trial protocols and understand impact on supply

  • Coordinate and track drug shipments

  • Monitor inventory at depots, sites, and distribution points

  • Perform drug accountability with depots/clinical sites and Sponsor inventories

  • Act as point of contact for third party storage, distribution, and packaging vendors

  • Maintain traceable documentation to support GXP activities

  • Has the potential opportunity to manage clinical projects

  • Partner with key stakeholders (including Quality Assurance and Regulatory Affairs) to ensure supplies are labelled and released for clinical site shipment for global clinical trials.

  • Design and/or review label text to meet product requirements and ensure compliance with US and international regulations.

  • Represent clinical supplies function at clinical trial team meetings; communicate plan and timelines to internal and external customers and partners.

  • Utilize appropriate software and IT systems to effectively manage key project activities.

EDUCATION/EXPERIENCE/SKILLS:

Education:

  • BS/BA degree in related discipline and at least three years of related experience; or,

  • MS/MA degree in related discipline and at least one year of related experience; or,

  • Equivalent combination of education and experience.

  • Certification in assigned areas is a plus.

Experience:

  • Typically requires a minimum of seven years of related experience and/or combination of education and experience.

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.