Kelly Services Clinical Study Manager (Clinical Research Associate) 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 Clinical Study Manager to join a leading biotherapeutics client.
Clinical Study Manager (Clinical Research Associate)
Objective of Position
The Clinical Study Manager (CSM) provides day to day clinical operations management of a clinical trial. Attends the study management team (SMT), may manage vendors, clinical monitors and clinical trials sites.
Essential Duties/ Responsibilities
May assist in reviewing clinical study protocols, informed consents, case report forms, monitoring plans, clinical study reports and other study-related documents
Assists in development of clinical studies and respective documents for company products
Assists in study / site evaluations start-up, conduct and close-out activities in addition to routine monitoring visits or co-monitoring, as required
May act as one of the primary contacts between the company and multiple clinical sites
Maintains close contact with sites by telephone, correspondence and on-site visits as required
Assists in preparing CROs, vendors, CRAs for a site monitoring visit to assure compliance with the study protocol, clinical trial material storage and accountability, GCP and FDA or other Health Authority regulations, and overall clinical objectives
Ensures preparation, management and participation in investigator meetings when required
Instructs investigators, study coordinators and their personnel regarding site compliance with the routine protocol, regulatory requirements and quality of data
Supports the training of Clinical Study Associates and / or be assigned as a buddy to colleagues
Interfaces, co-ordinates and addresses routine study issues with individuals in other functional areas
Supports the availability of clinical trial documentation and retrieves, processes and tabulates clinical or study compliance data to ensure smooth initiation, operation and timely completion of the clinical trial
Verifies accuracy of clinical data through comparison of the case report forms to patient records at the site and identifies and escalates discrepancies
Supports review of routine data, and preparation of safety, interim, and final study reports, and resolution of data discrepancies
Provides input into the selection of and grant contract negotiation with investigational sites and may conduct site training for the study
Supports the resolution of routine monitoring issues
Provides Clinical Operations guidance for complete and accurate databases for clinical studies
Supports analyses of study data and prepares clinical summaries as needed to support claims of safety and efficacy
Provides input in the setting and updating of study timelines for vendors
Provides input in CRO or vendor selection
Interacts with CRO personnel as needed and may oversee CRO management of 1-2 regions of a clinical trial
May manage one or more vendors for clinical trials in accordance with budgets and scopes of work
Possesses excellent verbal, written, interpersonal skills
Possesses good organization and planning skills
Ability to manage multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures
Ability to work both independently and in a team setting, including a matrix environment
Demonstrated expertise in relevant clinical operations activities
Experience in all phases (e.g., I, II, III) and stages (e.g., startup, maintenance, close out) of clinical operations
Demonstrates thorough knowledge and understanding of required regulations including FDA and
/ or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
Demonstrates knowledge of clinical trial design; understanding of the overall drug development process
Understanding of the regulatory environment and pathways globally, desirable
Demonstrated competence in adhering to and understanding standard business procedures (e.g., SOPs)
Proficient in using a variety of software programs (e.g., MS Office)
Requires the ability to sit or stand for extended periods of time
Minimum 2 years direct study management or relevant site or clinical experience in the pharmaceutical industry
Bachelor degree or equivalent education / degree in life science / healthcare or nursing field preferred
May involve 10% travel
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.