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5 days old

Senior Clinical Research Associate _ Fremont, CA

Kelly Services
Fremont, CA 94536
**Senior Clinical Research Associate _ Fremont, CA**


Kelly Services is currently seeking a Senior Clinical Research Associate for one of our top clients in San Diego, CA.


**Duration:** 6 months


**Pay:** $50/hr - $55/hr


**Shift:** Day shift


As the Senior Clinical Research Associate you work closely with Program Management to deliver high quality site monitoring and management for the Study Operations team within Clinical Shared Services.


+ Demonstrate the ability to work in a fast-paced environment and provide leadership to others on the team.

+ Take initiative and complete tasks with high attention to detail and accuracy.

+ Proactively communicate with investigators, colleagues, and vendors to ensure clinical quality and compliance.

+ Take great pride in mentoring others and delivering high quality results.

+ Possess a broad perspective and solid understanding of the clinical research processes.

+ Provides appropriate sponsor oversight of sites and mentorship to junior team members.

+ Works independently with minimal guidance and direction.

+ Conducts clinical research activities in accordance with Stryker SOPs and applicable regulations/guidelines.

+ Supports activities within various phases of clinical studies (i.e. study planning, site qualification and investigator selection, monitoring, closeout, etc.).

+ Manages overall clinical site activities in accordance with the Protocol, Monitoring

+ Plan, Good Clinical Practice (GCP), ICH guidelines and federal regulations.

+ Builds and maintains great working relationships with Clinical Research

+ Coordinators and Study PIs.

+ Identifies noncompliance and implements preventative and corrective actions.

+ Complete all training requirements on time.


**REQUIREMENTS**


+ A minimum of a Bachelors Degree (B.S. or B.A.) required or equivalent in health/science field (RN, BSN, MBBS, PharmD).

+ A minimum of 4 years Industry experience (Medical Device or Pharma) in a clinical study operations role (i.e. Clinical Trial Coordinator, Clinical Research Associate, or Clinical Trial Scientist) working directly for a Sponsor or CRO organization required.

+ A minimum of 3 years (36 months) of demonstrated independent site management responsibilities and data monitoring (source data verification) as a Clinical Research Associate experience required

+ Demonstrated independence conducting Site Qualification Visits, Site Initiation Visits, On-site AND Remote Interim Monitoring Visits.

+ Experience performing Site Close-Out Visits preferred.

+ Demonstrated independence performing timely Study Start-up activities as well as the timely activation of sites to enroll, for both Central IRB sites and Local IRB sites.

+ Working knowledge of GCP/ICH guidelines, federal and local regulations required.

+ Medical Device monitoring experience preferred.


Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Email stalvnl@kellyservices.com for questions about the position but please apply online to be considered for the position.


Why Kelly?


+ As a Kelly Services employee, you will have access to numerous perks, including:

+ Exposure to a variety of career opportunities as a result of our expansive network of client companies

+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career

+ Access to more than 3,000 online training courses through our Kelly Learning Center

+ Weekly pay and service bonus plans

+ Group-rate insurance options available immediately upon hire*


Apply Today!


*Available for purchase and administered by a designated third-party vendor


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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 (plus, did we mention we provide a ton of benefits ?). 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-05-03 Expires: 2021-06-03

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Senior Clinical Research Associate _ Fremont, CA

Kelly Services
Fremont, CA 94536

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