Kelly Services Senior Clinical Study Associate (Sr Clinical Trial Assistant) in South 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 full time opportunity in So San Francisco for a Sr Clinical Study Associate to join a leading biotherapeutics client.
Senior Clinical Study Associate (Sr Clinical Trial Assistant)
Objective of Position
The Senior Clinical Study Associate (Sr. CSA) will support the study management team (SMT) in multiple areas. Acts as a central contact for clinical operations for designated project communications, correspondence and associated documentation. Performs administrative tasks to support team members with clinical trial execution as needed.
Essential Duties/ Responsibilities
Assists study team with clinical study(ies) administration tasks and sites for adherence to protocol, GCP and company SOPs
Tracks timely enrollment against plan
Ensures quality of data generated from clinical sites and assists in resolving patient eligibility and protocol deviation issues
Tracks the progress of assigned clinical trials, such as study subject tracking, essential document tracking and sample tracking
Assists in the development of the structure of TMF and filing system and is responsible for filing and maintaining up-to-date study documents
Assists in the design, format and content of CRFs, study guides and subject instructions
Prepares, packages, and sends documents and materials to clinical trial sites and vendors as needed
Tracks and coordinates CRO and third-party vendor activities
Receives and reviews all regulatory documents from sites for accuracy and compliance to company SOPs and federal guidelines, tracks all information for reference and maintains documentation as required
Ensures that regulatory documents are updated in a timely and appropriate manner
Assists with the development of site tools and clinical trial start-up activities
Assists with guidance from study lead, clinical trial insurance to support study start-up
Coordinates Contracts Approval Process, including obtaining appropriate approvals and signatures for all clinical agreements in accordance with corporate policies to ensure compliance and standardization of process
Prepares, requests, and tracks Purchase Orders, invoices for contracted services across the clinical study(ies)
Reviews subject visit schedules, site budgets and clinical database to approve site payments
Confirms the accuracy of administrative data
Provides general support to the Clinical Operations team on other clinical trial-related duties and tasks, as required
Assists with the organization, management and conduct of internal team meetings, investigator meetings and other trial-specific meetings
Maintains knowledge through familiarity with clinical and scientific literature and participation in professional activities
Ensures compliance with policies and procedures
May be required to buddy / mentor a colleague
Basic knowledge of clinical trial operations, ICH and GCP Guidelines and other applicable regulatory requirements
Possesses excellent verbal, written, interpersonal skills
Possesses good organization and planning skills
Proficient in Microsoft Office
Requires the ability to sit or stand for extended periods of time
Bachelor’s degree in a scientific discipline preferred
2+years’ experience within the Pharmaceutical / CRO industry or equivalent site experience preferred
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.