Kelly is currently seeking a **Clinical Study Coordinator** for a long-term engagement with one of our Global Medical Device clients in Irvine, CA


*****PT and FT shift options available*****


This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.


**Summary of the Job:**

The position is responsible for assigned Clinical Research tasks including study coordination of post-market clinical studies, investigator-initiated studies (IIS), collaborative studies, real-world evidence and maintenance of evidence library.


**Responsibilities:**

Assist Clinical Director and/or research scientists with assigned clinical research tasks.

Specific responsibilities include:

Assists in daily management of post-market clinical research activities in the following responsibilities:

Supporting the Clinical Scientists in study management operations including contracting, processing invoices, and supporting publication related activities

Coordinates meetings and recording of meeting minutes as needed

Working collaboratively with legal/compliance and study institution/principal investigator on contract request, development, negotiation, and execution

Working with global medical/clinical colleagues in daily management of research projects in other countries outside of United States

Using sound judgment to assure all clinical research activities are in compliance with legal, regulatory, and company process requirements

Manages clinical study milestones, invoices, and payments

Managing device orders, shipments, and returns as needed

Assists the Clinical Director in management of internal evidence database and monthly literature review

Performs other duties assigned as needed


**Requirements:**

Minimum of B.S. in scientific related discipline preferred.

Candidates with good organization and administrative skills without B.S may be considered

0-2 years of experience in the pharmaceutical/biotech/medical device/CRO industry.

Experience with clinical study management and clinical research contract negotiation highly preferred

Knowledge of medical device/pharmaceutical industry processes preferred

Excellent oral and written communication skills

Excellent organizational skill

Ability to work in a collaborative and multi-disciplinary environment

Must be detail oriented, highly organized, and able to work independently

Ability to multi-task in a fast paced environment


**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. 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)