Kelly Services Clinical Documentation Specialist in San Francisco, 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 San Francisco area for a Clinical Documentation Specialist to join a leading biotherapeutics client.
Clinical Documentation Specialist
We are currently seeking a Senior Clinical Documentation Specialist who will play a crucial part on the clinical trial team and is considered a key contact before, during and after the clinical trial concludes. The position itself shall assist in the coordination and management of documentation associated with conducting clinical studies.
This position shall assist CRAs and other functional areas with the management of essential documents, and may also serve as a resource during internal and/or external audits as well as regulatory inspections.
This position contributes to and supports the company s research and development efforts to create high value therapeutics to address unmet medical needs.
The successful candidate shall work on assignments requiring considerable judgment and initiative. Understand implications of work and makes recommendations for solutions and determine methods and procedures on new assignments.
This position provides support to clinical research including, but not limited to, maintenance of essential documentation, clinical trial tracking and information retrieval.
Manages access and organization of the controlled clinical documentation storage on-site, including ensuring the defined file structure is maintained.
Manages the exchange of essential documents with external service providers.
Maintains quality check schedule and performs periodic inventories of study/project TMF to ensure completeness.
Assists with off-site archiving activities including budget, cataloguing process, and document retrieval.
Performs all responsibilities in accordance with Standard Operating Procedures, established guidelines, work instructions, and appropriate industry and Good Clinical Practices standards.
Typically, 6 years industry experience working in the Pharmaceutical, Biotechnology or other related industry is required.
Equivalent experience may be accepted.
Strong attention to detail.
Good communication skills both oral and written are a must.
Good computer skills are required, working knowledge of MS Word, Excel, and PowerPoint is required.
Excellent organizational skills are required.
Requires a minimum of a High School diploma. An Associate degree is a plus.
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.