The Emmes Company, LLC ("Emmes") is searching for a *TMF** Specialist* based out of our Rockville, Maryland or Frederick, Maryland offices. Emmes provides flexibility for the office location or work remote preference dependent upon position.
Emmes is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over seven hundred staff worldwide with offices located in Frederick, Maryland, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.
Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.
* Primary Purpose *
The TMF 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.
* Responsibilities *
* 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.)
* Assists with 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
* 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
* 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
* 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
* Assists project staff in tracking that essential documents are received and maintained across assigned studies and sites
* 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
* Collaborates with CRAs to ensure support for the collection and tracing of documents
* 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
* Responsible for tasks associated with posting studies to ClinTrials.gov
* Assists with activities for off-site archival of clinical and TMF records
* Experience *
* Bachelor's degree, preferably in a scientific discipline
* Minimum 1-2 years or more of experience, with electronic Trial Master Files (eTMF) solutions highly preferred
* Working knowledge of Good Clinical Practices (GCP) and TMF governing regulations, such as DIA Reference Model preferred
* Ability to access technical information and read study materials such as protocols, MOPs, and User Guides, and understand the overall purpose and objectives of the documents
* Knowledge of clinical research concepts and able to work in a team environment
* Excellent organizational and planning skills
* Ability to build and maintain positive relationships with management, peers, and subordinates
* Excellent written and verbal skills required
* Display strong analytical and problem-solving skills
* CONNECT WITH US!! *
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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.