Clinical Trials Operations Specialist

Axle•Rockville, MD

About The Position

Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH). Axle is looking to add a driven, flexible, organized, and meticulous Clinical Trials Operations Specialist to our dynamic team. The Contractor(s) shall provide services in support of the overall functions of the Division of Microbiology and Infectious Disease (DMID), Office of Clinical Research Affairs (OCRA).

Requirements

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.

Nice To Haves

Experience in regulatory inspections from the US FDA or similar government regulatory authorities is preferred.
Experience conducting or overseeing audits is preferred.
Experience working at a clinical research site or overseeing multicenter clinical research is preferred.
Experience in the NIH or other government agency is preferred.

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.