Clinical Study Administrator/Coordinator Job Listing at Kelly Services in Irvine, CA (Job ID 9592705)

Description

Clinical Study Coordinator

Job Description:
This professional will report to Clinical Science and External Research (CSER) Leaders in the management of assigned clinical projects for the client to support the development of the evidence generation and dissemination strategy of assigned products. S/he will manage activities with supervision consistent with level of experience. S/he will be responsible for supporting clinical activities and other study-related tasks, as well as applicable department procedures.

The Clinical Study Coordinator will or may be responsible for:

• Coordinating postmarket clinical studies, investigator-initiated studies (IIS), collaborative studies, and real-world evidence studies
• Supporting Clinical Scientists in study management operations including contracting, filing, processing invoices, and supporting publication related activities
• Scheduling meetings, accurately drafting and recording meeting minutes, and following-up on action items
• Collaborating with Company 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 countries outside of the United States
• Using sound judgment to assure all clinical research activities are in compliance with Legal, Regulatory, and Company process requirements
• Tracking clinical study milestones, invoices, and payments
• Managing device orders, shipments, and returns
• Maintaining the internal clinical evidence database and assisting with monthly literature reviews
• Supporting Clinical Scientists with the management of Clinical Events Committees for assigned clinical studies
• Performing other assigned duties, as needed

Qualifications

• A minimum of a Bachelor's degree in relevant scientific discipline
• At least 2 years of experience in the pharmaceutical/biotech/medical device/CRO industry required; experience with clinical study management and clinical research contract negotiation highly preferred
• Medical device experience is preferred; cardiovascular experience is a plus
• Effective time management, organizational and prioritization skills
• Strong project management skills with meticulous attention to detail and accuracy
• Professional verbal and written communication skills; experience interacting with external investigators preferred
• Proven ability to collaborate in a cross-functional team environment while having the skillset and confidence to work independently, as needed
• Must be reliable, and flexible in adapting to shifting business needs while contributing to a multidisciplinary and fast-paced working environment
• Must be a highly motivated, responsible, fast-learner, and team-oriented collaborator willing to take ownership of his/her contributions to the advancement of the collective CSER goals and objectives
• Proficient in Microsoft Office
• This position is in Irvine, CA

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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