Axle · 19 hours ago
Clinical Trials Operations Specialist
United States
Full-time
Remote
Mid Level
$100K/yr - $110K/yr
3+ years expAxle is a bioscience and information technology company focused on advancements in translational research and biomedical informatics. They are seeking a Clinical Trials Operations Specialist to manage essential documents for clinical trials, ensure compliance with industry standards, and support the Division of Microbiology and Infectious Disease.
BiotechnologyHealth CareInformation TechnologySoftware
Responsibilities
Manage the oversight of sponsor essential documents/ records files for multi-center studies and electronic trial master files
Advance the writing of documents as part of the quality management system (SOPs, policies, audit reports, etc.), by both actively leading the development of documents and facilitating working groups to collaborate and write documents
Stay current with changes to current industry standards and applicable regulations for quality in clinical research
Conduct quality assurance activities such as internal audits, reviews of regulatory documents, drafting summary reports for division leadership, and others as assigned
Participate in preparations for regulatory inspections, which may include reviewing inspection readiness plans, mock inspections, and risk-based management of program inspection quality events
Assist in resolving compliance issues at clinical sites, clinical vendors, and contracted research facilities; and provide assessment of the impact of any deficiencies
Provide guidance to other groups in DMID that are funding, overseeing, and implementing clinical research to understand how clinical research is supported by DMID
Based on understanding of Division operations, look for ways to standardized processes to improve quality and/or facilitate efficiency
Qualification
Required
Bachelor's degree in a related discipline
Minimum of 3 years of experience in clinical research or a related field
Thorough knowledge of clinical trial documentation including Essential Documents/Records according to ICH
Must be detail-oriented with strong organizational skills
Experience with US and international Good Clinical Practice (GCP), guidance documents, and industry best practice in all areas of a GxP environment
Extensive experience with electronic trial master file systems and electronic data capture
Excellent communication skills both verbally and written; and across functions internally and external
Ability to organize, prioritize and deliver tasks & projects according to pre-defined deliverables
Ability to effectively build and maintain relationships with multiple departments and external entities (e.g., Investigator sites, clinical Vendors/CROs) in order to effectively solve problems
Excellent multi-tasking, analytical, organizational and teamwork skills
Ability to troubleshoot, identify root cause and systematically resolve problems
Ability to produce high-quality work on complex problems with cross-functional involvement
Proficient in Window based software to include Excel, Word
Preferred
Experience in regulatory inspections from the US FDA or similar government regulatory authorities
Experience conducting or overseeing audits
Experience working at a clinical research site or overseeing multicenter clinical research
Experience in the NIH or other government agency
Benefits
100% Medical, Dental & Vision Coverage for Employees
Paid Time Off (Including Holidays)
Employee Referral Bonus
401K Match
Tuition reimbursement and professional development opportunities
Flexible Spending Accounts:
Healthcare (FSA)
Parking Reimbursement Account (PRK)
Dependent Care Assistant Program (DCAP)
Transportation Reimbursement Account (TRN)
Company
Axle
At Axle, we are driven by the mission to accelerate discovery and enhance organizational outcomes by revolutionizing operations with our innovative solutions.
501-1000 employees
H1B Sponsorship
Axle has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (40)
2023 (61)
2022 (30)
2021 (19)
2020 (38)
Funding
Current Stage
Late StageLeadership Team
Gary Mays
Chief Operating Officer
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