Clinical Documentation Associate Jobs

CONTRACT/REMOTE

MUST HAVES:

• AA or BA/BS degree and 5 years clinical experience including organizing and coordinating Trial Master Files for clinical trials
• High level of competency with Veeva eTMF and knowledge of the TMF Reference Model, supported by DIA.
• Familiarity with US FDA, ICH/GCP, and European Regulatory Authority requirements as applicable to a study (or the countries where a study is conducted)

Position Summary

This position supports and maintains the Trial Master File (TMF) for study teams. They also

facilitate providing teams and partners with TMF Health updates to support inspection

readiness.

Responsibilities

• Interact with clinical study sites to collect/process documentation required during all phases of assigned clinical studies. Participate and provide updates/information related to role at clinical study team, internal, and vendor meetings, write minutes for such meetings upon request.
• Support audit/inspection activities, internal Compliance/Quality procedures and process improvement when requested.
• Assist in management of internal and external assessments and corrective/preventive actions .
• Accountable for delivery of assigned TMF activities in accordance with project requirements/timelines and as outlined in the TMF Plan.
• Train/mentor departmental and vendor staff on file management systems and processes.
• Classify and index electronic TMF (eTMF) and clinical development documentation with accurate attributes and metadata according to department standards.
• Assist with handling/coordinating/tracking study related product shipments, relevant forms, and site materials/documentation.
• Monitor TMF health/report metrics throughout the study according to TMF plan; identify and record quality issues; provide solutions and resolve issues, as appropriate.
• Track and manage study related activities, including: Trial Master File (TMF) and electronic TMF (eTMF) study documents (including first pass quality review of documents as assigned), e.g., site monitoring visit reports, site startup essential documents.
• Follow processes and procedures to support set up, maintenance, and archiving of TMF for assigned projects.
• Assist with clinical appendices of various study reports (i.e., final clinical study report).
• Assist in maintaining the integrity of the Clinical secure file room storage area(s).
• Processing/coordinating the flow of site and vendor contracts.
• Serve as TMF contact and Subject Matter Expert for the clinical study team and supporting cross-functional departments to ensure high quality documentation.
• Perform/volunteer for other duties and special projects as assigned or appropriate for skill set.

Qualifications and Skills Required

The ideal candidate has:

• Familiarity with US FDA, ICH/GCP, and European Regulatory Authority requirements as applicable to a study (or the countries where a study is conducted). GCP inspection experience preferred.
• Proficient in Microsoft Word, Excel, and PowerPoint. Must be able to handle multiple projects at a time and have strong attention to detail.
• Ability to establish and maintain effective working relationships.
• Able to quickly learn and adapt to new systems and technology.
• Good organizational and problem-solving skills, able to work independently.
• High level of competency with Veeva eTMF and knowledge of the TMF Reference Model, supported by DIA.
• Prefer candidates with AA or BA/BS degree and 5 years clinical experience including organizing and coordinating Trial Master Files for clinical trials.
• Good written and verbal communication skills including excellent command of English.
• Ability to lift file boxes of documents/files onto and off of shelves and carts.
• Efficient and effective time management skills with ability to successfully manage competing priorities.