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Sr. Clinical Research Specialist
17011 Red Hill Avenue Irvine, CA 92614 US
Job Description
*Depending on experience
Summary:
The main function of a Sr. clinical research specialist is to perform clinical site management activities including: reviewing informed consent forms (ICFs) to ensure compliance with regulatory requirements, maintaining site essential documents in alignment with ALCOA+ standards, performing database quality checks to support data integrity, and communicating study progress and escalations. This position will also support trial master file (TMF) preparation for PMDA submission, prepare reports for Study Health meetings and Centralized Monitoring meetings, and support audit preparation activities.
Key Responsibilities:
• Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study phases
• Conduct in-house and site (if applicable) reviews of associated documentation and participate in internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, internal SOPs, and US and OUS regulations
• Assess current processes, identify opportunities and propose solutions to improve process efficiency within and across related functional areas
• Partner with cross-functional teams (e.g., clinical data management, field teams) with query management, data reviews and resolution
Additional Skills:
• Clinical background, familiar with clinical study process, monitoring, GCP and clinical study relevant regulations.
• High compliance requirements and understand that rights and well-being of human subjects should be protected during clinical study.
Education and Experience:
• Bachelor's Degree or equivalent in related field
• 5-7 years of experience required
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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