Clinical Study Documentation Specialist – eTMF Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Facilitate the initiation and ongoing management of clinical trials by preparing and submitting essential study documents, including protocols, informed consent forms, investigator brochures, and amendments, to IRBs and other regulatory bodies.

• Ensure the accuracy and currency of clinical study files and documentation, comprising licenses, staff certifications, training records, and equipment logs.

• Organize and perform regular audits of study binders and systems to verify that documents are valid, complete, and compliant with protocol specifications.

• Act as the point of contact among internal teams, research sites, IRBs, and sponsors.

• Monitor study progress, milestones, and document statuses within CTMS, IRB portals, spreadsheets, and sponsor systems.

• Assist with site onboarding and study activation throughout the duration of the trial.

• Engage in both internal and external meetings, including site calls and sponsor interactions.

• Ensure adherence to federal, state, and local regulations, GCP, HIPAA, FDA, OHRP, and other relevant guidelines.

• Aid in the creation and delivery of GCP training programs.

• Keep abreast of changes in clinical regulatory processes and contribute to the development of new procedures or SOPs.

⛳️ Requirements

• Associate's degree.

• Two years of experience in preparing and submitting documents to Institutional Review Boards (IRBs).

• Solid understanding of clinical research documentation, clinical regulatory processes, and protocol development.

• Proficient in Microsoft Office Suite (Word, Excel, Outlook) and adept at navigating internet-based systems for regulatory and trial management.

• Excellent organizational abilities and meticulous attention to detail in documentation and communication.

• Capability to manage multiple studies and competing priorities with minimal supervision.

• Successful completion of pre-employment requirements, including a criminal background check, drug screening, and reference check.

• Familiarity with ICH-GCP, FDA, DHHS, and OHRP regulations and guidelines.

• Experience with electronic clinical trial management systems (CTMS).

• Completion of Good Clinical Practices (GCP), Human Subject Protection, and HIPAA training.

• Willingness to address after-hours issues in rare instances when urgent regulatory support is necessary.

🏝️ Benefits

• Highly competitive and inclusive medical, dental, and vision coverage options.

• Health Savings Account for medical and dependent care expenses.

• Flexible Spending Account to cover specific out-of-pocket expenses.

• Paid time off, which includes vacation, sick leave, and holidays.

• 401k match along with financial planning tools.

• Long-term disability (LTD) and short-term disability (STD) insurance coverage, plus voluntary benefit options.

• Employee Assistance Program.

• Pet Insurance.

• Legal Assistance.

• Tuition Assistance.