CRO-Senior Documentation Specialist

Job Details Job Location LOC400 CRO Remote - New Providence, NJ Remote Type Fully Remote Sr. Documentation Specialist (CRO) Job Title: Senior Document Specialist Department: Regulatory Operations Ideal candidate: 2+ years at a CRO w/trial master file experience Joining our team means stepping into a dynamic environment where growth is at the heart of everything we do. You'll have the opportunity to collaborate with all departments, gaining exposure to various facets of the business and sharpening your skills along the way. We foster a highly supportive and collaborative culture, ensuring that every voice is heard and valued. With remote work flexibility, you'll enjoy the benefits of working from home while still maintaining high visibility within the organization. Plus, we're deeply committed to delivering top-tier quality in everything we do, and your contributions will help us reach even greater heights. Job Description: The Senior Document Specialist will support the Regulatory Operations department by managing and overseeing the electronic Trial Master File (eTMF). This position focuses on eTMF management and incorporates some regulatory duties, with oversight from the Regulatory Operations Specialist, ensuring the efficient and compliant execution of clinical trials. The Senior Document Specialist works closely with the Regulatory Operations team, study sites, and other stakeholders to maintain high documentation and regulatory compliance standards. Responsibilities: Manage, organize, and maintain essential study documents in the eTMF, ensuring accuracy and accessibility. Perform quality control checks to ensure compliance with ICH GCP Guidelines and the DIA eTMF Reference Model. Reconcile and review documents between the Investigator Site File (ISF) and the eTMF for consistency. Assist in clinical trial start-up and regulatory compliance under the guidance of the Regulatory Operations Specialist. Collect, create, and review essential regulatory documents (e.g., FDA Form 1572) per SOPs and study plans. Serve as a point of contact for IRB submission-related activities, coordinating with the Regulatory Operations Specialist. Support document receipt, processing, and tracking in the eTMF or binder systems. Ensure required documentation is available by coordinating with study sites and relevant parties. Aid in the development and adaptation of site-specific informed consent forms for local compliance. Assist with internal and external eTMF audits to ensure SOP and regulatory guideline compliance. Conduct Quality Control Reviews of the eTMF with functional teams and address feedback. Address audit findings and quality control issues throughout the study, with support from the Regulatory Operations Specialist. Contribute to eTMF management planning and milestone setting. Maintain eTMF file structure and prepare compliance reports for management. Education/Experience: High school diploma required, bachelor's degree in biological sciences or related field preferred. Bachelor's degree or equivalent combination of education and 2+ years of eTMF/research experience required. Knowledge of GCP, regulations, eTMF compliance, and auditing processes. Experience with eTMF systems (Veeva preferred) and DIA eTMF Reference Model. Strong understanding of regulatory requirements and clinical trial documentation. Skills and/or Abilities: Ability to enter data into PC accurately, including experience working with Microsoft Office. Ability to work effectively and efficiently handling multiple tasks simultaneously. Ability to facilitate a teamwork philosophy with a positive attitude.

Created: 2024-10-19