Clinical Contracts Administrator (Irvine)
5 days ago
Irvine
Kelly Science and Clinical FSP is currently seeking a Clinical Contacts Administrator for a long-term engagement in Irvine, CA with one of our Global Pharmaceutical 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. Clinical Research Contracts Administrator ESSENTIAL DUTIES AND RESPONSIBILITIES Under general direction of Clinical Research management, and in accordance with all applicable Regional, State and local laws/regulations and corporate client procedures and guidelines, this position will: • Initiate agreement requests per company SOPs and legal requirements., • Manage the end-to-end contracting process for agreements including, but not limited to, NDA, consulting, and vendor agreements., • Serve as the primary point of contact between Clinical Research, Legal, HCC/Compliance, Privacy, and external parties, • Track agreement status, approvals, and execution timelines to ensure alignment with study milestones, • Ensure all agreements are fully executed prior to engagement or information exchange, • Maintain accurate and audit?ready records of executed agreements and related documentation, • Support fair market value (FMV) confirmation and documentation, as applicable, • Communicate agreement status and timelines to study teams and stakeholders, • Participate in inspection readiness activities by providing agreement documentation as requested, • Actively participate in study team meetings and project updates., • May assist in processing consulting/HCP payments, • May participate in process improvement activities within the department., • May perform other related duties assigned as needed., • Responsible for communicating business-related issues or opportunities to next management level., • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures REQUIRED EDUCATION/TRAINING and/or EXPERIENCE: • Bachelor’s Degree or higher with 0-4 years of work-related experience, • Prefer a degree in the sciences, • Prefer knowledge of clinical research, • Prefer medical device experience in the cardiovascular field REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES: • Ability to use PC and associated software., • Excellent PowerPoint, Word, Excel skills., • Excellent written and oral communications skills., • Ability to multi-task, excellent attention to detail, and organizational skills., • Working knowledge of Good Clinical Practices (GCP) is desirable., • Knowledge of project management tools is desirable.