Senior Clinical Research Specialist

Kelly Science and Clinical FSP is currently seeking a Senior Clinical Research Vendor Specialist in Irvine, CA with one of our Global Medical Device clients. This position is hybrid. 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.

Senior Clinical Research Vendor Specialist

Hybrid: Onsite in Irvine, CA every T/TH/Every other Friday

Job Summary:

Under general direction, the Senior Clinical Research Vendor Specialist is responsible for the oversight and coordination of external vendors supporting one or several clinical trials within the Clinical R&D Department. This role ensures vendor performance aligns with study timelines, regulatory requirements, and budget expectations, while fostering strong partnerships across internal teams and external collaborators.

Duties & Responsibilities:

• Lead vendor selection, qualification, and contracting processes for clinical studies (e.g., CROs, labs, imaging, eCOA, IRT).
• Manage vendor relationships and performance throughout the lifecycle of clinical trials.
• Oversee vendor compliance with study protocols, GCP, and regulatory requirements.
• Coordinate RFPs, bid defenses, and contract negotiations in collaboration with Procurement and Legal.
• Monitor vendor deliverables, timelines, and key performance indicators (KPIs).
• Support budget development, payment processing, and financial tracking related to vendor activities.
• Facilitate regular vendor meetings and issue resolution.
• Ensure documentation of vendor oversight is audit ready.
• Collaborate with cross-functional teams including Clinical Operations, Regulatory, Quality, and Finance.
• Contribute to protocol development and operational planning to ensure vendor alignment.
• Support vendor-related activities in post-market clinical follow-up (PMCF) and post-approval studies (PAS).
• Maintain awareness of industry trends and best practices in vendor management.
• Mentor junior team members or support training initiatives.

Experience & Education:

• Education: Minimum of a bachelor’s degree in Life Sciences, Healthcare, or related field required. Advanced degree (MS, MBA) preferred.
• Clinical Experience: BS with at least 5 years, or MS with at least 3 years of relevant clinical research experience.
• Vendor Management: Minimum 2 years of direct vendor management experience in clinical trials.
• Industry: Experience in the medical device industry is highly preferred.
• Regulatory Knowledge: Familiarity with GCP, ISO 14155, and FDA regulations required.
• Certifications: Relevant certifications (e.g., CCRA, CCRP, PMP) are a plus.

Required Knowledge, Skills & Abilities:

• Strong understanding of clinical trial operations and vendor oversight.
• Proven ability to manage multiple vendors and complex projects.
• Excellent negotiation, communication, and organizational skills.
• Proficiency in clinical trial management systems and Microsoft Office tools.
• Ability to lead small study teams to deliver critical milestones.
• Leadership Qualities: Ability to develop collaborative relationships, participate in process improvement, and ensure all deliverables are met on time and within budget.

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.