Senior Clinical Research Specialist
Duration - 1 Year
Location - Irvine, CA
Max Pay - $50.00-$60.37/hour
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, Edwards 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
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.
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