Job Description

Kelly Science and Clinical FSP is currently seeking a Clinical Study Administrator/Coordinator for a long-term engagement in Irvine, CA with one of our Global Pharmaceutical clients. 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, Vision, 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.

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

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