Clinical Documentation Specialist

Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a Clinical Documentation Specialist at a prestigious Fortune 500® company working in San Francisco, CA. 

 

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “Submit Resume” button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position (Brooke.Schoen@kellyservices.com) however your resume must be received via the “Submit Resume” button included within.

 

Job Title: Clinical Documentation Specialist

 

Responsibilities

Assists in the coordination of documentation associated with conducting clinical studies. Assists CRAs and other clinical staff with management of trial master file documents, SOPs and record archiving. Supports the creation of standardized clinical trial tools, processes and SOPs.

Provides support to clinical research including, but not limited to, maintenance of documentation, clinical tracking and information retrieval. Assists in management of access and organization of the controlled clinical document storage on-site or third-party providers, including ensuring the defined file structure is maintained. Assists with the exchange of TMF documents with external service providers. Maintains file QC schedule and perform periodic inventories of study/project TMFs to ensure completeness. Assists with off-site archiving activities (including budget, cataloguing process, and document retrieval). Assists in coordinating communications, correspondence and associated documentation. Performs duties such as, clinical form design, and filing of correspondence, lab reports, Clinical Monitoring Reports, and other study documents. Assists with document retrieval. Maintains and ensures all documentation are in a state of audit-readiness. Assist in collection, dissemination, and/or tracking of regulatory documents as required. Performs all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, and appropriate industry and Good Clinical Practices standards. Supports other projects as assigned. Performs other tasks as assigned.

 

Skills 
Strong attention to detail is a must. 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. Must have an ability to multi-task.


Qualifications

Requires a minimum of a High School diploma. An Associate degree is a plus. Equivalent experience may be accepted. A minimum of 1 year industry experience working in the Pharmaceutical, Biotechnology or other related industry is highly preferred.

 

We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyservices.com.

 

Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world.

Kelly Services is an Equal Opportunity Employer

 

 

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 90 of the Fortune 100 companies and found opportunities for more than 10,000 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.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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