Lotus Clinical Research 100% Remote
Who we are: www.lotuscr.com
About the role:
The TMF Specialist supports Regulatory Operations by managing, reviewing, and approving site-level documentation within the electronic Trial Master File (eTMF). This role ensures timely and accurate filing of essential documents, maintains audit readiness, and contributes to overall study compliance. The TMF Specialist collaborates with internal teams and provides operational support across a variety of TMF-related tasks, helping to uphold documentation standards and regulatory expectations.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.
Other duties may be assigned. Employee performs all, part, and/or any combination of the duties listed below.
- Review, process, and approve Trial Master File (TMF) documents submitted to the electronic TMF (eTMF), ensuring alignment with the electronic Investigator Site File (ISF) and study-specific filing requirements.
- Validate document quality by checking metadata accuracy, naming conventions, and version control prior to approval.
- Communicate with internal stakeholders to clarify document discrepancies and support timely resolution.
- File documents promptly to maintain a complete, inspection-ready TMF throughout the study lifecycle.
- Update and monitor the Expected Documents List (EDL) to reflect current document status in accordance with sponsor expectations and regulatory standards.
- Use designated systems and tools to manage document flow, track submissions, and flag potential quality issues; assist in retrieving outdated or missing documents as needed.
- Provide operational support to Regulatory Specialists and Senior TMF Specialists across a variety of tasks, including but not limited to the collection and preliminary review of Essential Documents.
- Participate in TMF audit preparation activities and support audit response efforts by organizing and verifying documentation.
- Contribute to TMF-related process improvement efforts and assist with department initiatives that enhance document quality and compliance.
- Respond to document-related questions from internal teams and external partners, escalating complex issues to senior staff as appropriate.
- Maintain familiarity with current Lotus CRO and Sponsor SOPs, TMF best practices, and applicable regulatory guidelines; suggest improvements to streamline TMF workflows.
- Assist with document intake and categorization from sites and vendors, ensuring accurate routing and timely processing.
- Monitor TMF completeness reports and escalate gaps or delays to senior staff for resolution.
EDUCATION and/or EXPERIENCE
- Bachelor’s degree in biological sciences or a related field preferred.
- At least 1 year of experience in clinical research, document management, or regulatory operations.
- Experience with electronic document management systems and eTMF platforms (e.g., Veeva Vault) strongly preferred.
- Familiarity with Good Clinical Practices (GCP), ICH guidelines, and the DIA TMF Reference Model is desirable.
SKILLS and/or ABILITIES
- Knowledge of regulatory requirements for clinical research, including GCP and ICH guidelines
- Knowledge of Good Clinical Practices (GCP), regulations/guidelines, auditing processes, and compliance requirements in relation to TMF
- Experience with electronic document management system(s) and eTMF with Veeva eTMF experience strongly preferred
- Working knowledge of the DIA TMF Reference Model is strongly preferred
- Strong working knowledge of procedures and guidelines in Clinical Research
- Excellent organizational and coordination skills
- Solid understanding of the process of clinical drug development
- Strong written and verbal communication skills
- Exceptional attention to detail
- Strong interpersonal skills
- Proficiency in Microsoft Office
- Effective time management and organizational skills
- Ability to handle multiple tasks simultaneously
Skills Required
- At least 1 year of experience in clinical research, document management, or regulatory operations
- Experience with electronic document management systems and eTMF platforms
- Experience with Veeva eTMF or Veeva Vault
- Knowledge of regulatory requirements for clinical research, including GCP and ICH guidelines
- Knowledge of Good Clinical Practices, auditing processes, and TMF compliance requirements
- Working knowledge of the DIA TMF Reference Model
- Strong working knowledge of clinical research procedures and guidelines
- Proficiency with Microsoft Office
- Strong written and verbal communication skills
- Strong organizational, coordination, interpersonal, and time-management skills
- Exceptional attention to detail and ability to handle multiple tasks simultaneously
- Bachelor's degree in biological sciences or a related field
What We Do
ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late stage neuroscience drug development. With 21 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally. The ERG portfolio of sites we own consists of Woodland International Research Group, Woodland Research Northwest, Midwest Clinical Research, Pacific Research Network, Clinical Pharmacology of Miami, Brain Matters Research, Neuropsychiatric Research Center, Richmond Behavioral Associates, Finger Lakes Clinical Research, Endeavor Clinical Trials, and HD Research, all supported by an industry leading centralized infrastructure located in New Jersey. ERG offers consulting services to pharmaceutical and CRO clients, including access to key opinion leaders in Schizophrenia, Pain, Alzheimer’s disease, Sleep Disorders, Depression, Hepatic/Renal Impairment, Podiatry and Clinical Pharmacology. This includes Rater Training Services, Centralized Data Services (ECG, PSG, EEG, qEEG, Actigraphy), Medical Writing Services, Study Feasibility and Site Recommendation ERG also offers general consulting in study design, protocol review and budget planning, vendor resources, Scientific Advisory Board Planning and Implementation, study feasibility and site recommendations.
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