Regulatory Document Specialist
We are searching for a Regulatory Document Specialist located in our Rockville, Maryland or Frederick, Maryland office. We provide flexibility for office location preference, dependent upon position.
The Regulatory Document Specialist is responsible for the overall management and quality maintenance of essential clinical trial and other designated documents, including the set up and maintenance of the Trial Master File (TMF), with a strong focus on ensuring that routine document management operations are performed with adherence with SOPs (Project and Corporate) and ICH/GCP/regulatory guidelines. This position plays a key role in both paper and electronic TMF system management, by filing, organizing and maintaining paper and/or digital records and coordinating the document management activities performed by third parties, such as vendors, clinical sites, collaborators, as well as other internal and external team members, as required.
Performs key TMF system administrator role and duties in accordance with the company guidelines and work instructions (e.g., TMF set-up, quality management, reports and metrics, TMF quality control (QC)/ quality assurance (QA) activities, etc.)\t
Accountable for the overall TMF quality and completion, including appropriate document filing and maintenance, cross-functional document coordination, including third party documents and TMF tracking and reporting to internal and external customers\t
Ensures the TMF file structure is in compliance with applicable company approved TMF configuration, with reference to ICH Guidelines for Good Clinical Practice, Good Documentation Practices and the DIA TMF Reference Model, as required\t
Ensures that all new and updated record information is accurately entered in the appropriate records management databases, such as TMF, for inspection readiness and highest quality of document governance\t
Ensures that all assigned records are maintained in accordance with the company eTMF and/or other electronic data room storage SOPs, processes and data structure\t
Develops and maintains company's digital records/TMF training materials and guidelines and performs training and/or coaching of new and existing staff as required\t
Assists project staff in tracking that essential documents are received and maintained across assigned studies and sites\t
Verifies receipt, reviews for identification and consistency, sorts, separates, photocopies, prints, scans, indexes, labels, and files a variety of clinical, regulatory and other non-clinical documents, as assigned\t
Ensures customer requests for retrieval, reproduction, and re-filing of requested records or electronic images (e.g. PDF, jpeg) are met in a timely manner\t
Manages activities for off-site archival of clinical and regulatory records\t
Other duties as assigned
Bachelor's degree from a university is preferred; however, the combination of experience and training will be taken under consideration\t
1-2 years industry experience with relevant document management experience (e.g, Records Information Management, library sciences, etc.)\t
1 year or more of experience with electronic Trial Master Files (eTMF) solutions is required\t
Working knowledge of Good Clinical Practices (GCP) and TMF governing regulations, such as DIA Reference Model\t
Thorough understanding of records management requirements in Drug Development\t
Experience with coordinating document management activities performed by third parties, such as clinical vendors\t
Knowledge of clinical research concepts and able to work in a team environment\t
Experience in line-management and/or mentoring less experienced staff is a plus\t
Excellent organizational and planning skills\t
Ability to build and maintain positive relationships with management, peers, and subordinates\t
Excellent written and verbal skills required\t
Display strong analytical and problem-solving skills
Why Kelly Â® ?
With Kelly, you'll have access to some of the world's highest regarded scientific organizations-providing you with opportunities to work on today's most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you'll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career-connect with us today.
About Kelly Â®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at ~~~