Records Management Associate

Summary of Responsibilities:

• This position will be responsible for maintaining the paper and electronic documents for the electronic Trial Master File (eTMF) in accordance with regulatory, legal, and other relevant guidelines.
• Store and retrieve documents as necessary from archive or long-term storage.
• Maintain security of document storage area.
• Collect, index and store newly received paper documents.
• Utilize electronic imaging and quality-control management applications to maintain the electronic trial master file in compliance with Good Clinical Practices and other relevant guidelines.
• Assist the business with the migration of paper documents into the eTMF system.
• Maintain document quality standards and quality check document attributes for completeness and accuracy.
• Perform various other document management tasks using the appropriate hardware and software and assist with projects as required.
• Maintain the archives by sending and retrieving archive boxes, entering information into the archive database, interacting with personnel using the archives, query the database according to user's requests.
• Maintain knowledge and awareness of regulations and relevant clinical trial guidelines.
• Demonstrate working knowledge of computer skills at an advanced level.
• Maintain knowledge base of information to respond to complex questions pertaining to aspects of records management.
• Maintain knowledge of current status for multiple projects simultaneously pertaining to aspects of records management.
• Maintain the filing records to enable quick retrieval of documents.
• Implement creativity; assist in the identification of new processes, procedures, information, and opportunities to improve departmental functions.
• Able to present capabilities in regard to Records Management to clients.
• Able to describe tasks associated with aspects of Records Management to auditors during client and regulatory inspections.
• Ability to lead a project with minimal assistance from supervisor.
• Able to train others, both formally and informally.

Qualifications (Minimum Required):

• Bachelor's Degree in the Life Sciences, Records Management or Library Sciences.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Core Focus on the Customer.
• Innovate and Change.
• Pursue Scientific and Process Excellence.
• Work with Others.
• Achieve Results.
• Ability to work independently.
• Excellent interpersonal skills.

Experience (Minimum Required):

• Minimum 2 years' experience working in a records management environment; or equivalent combination of education, training, and experience. Extensive knowledge of Regulatory/Clinical documents.
• Must be familiar with record retention requirements for the pharmaceutical industry.
• Extensive experience working in clinical electronic systems
• 1+ years of experience working with clinical trial documentation.
• Understanding of ICH/GCP guidelines.
• Extensive knowledge of Microsoft Office products, web-based applications, and Adobe Acrobat Standard, plus the ability to apply related knowledge regarding scanning and other software programs.

Preferred Qualifications Include:

• Bachelor's Degree in the Life Sciences, Records Management or Library Sciences.
• Minimum 2 years' experience working in a records management environment; or equivalent combination of education, training, and experience. Extensive knowledge of Regulatory/Clinical documents.
• Must be familiar with record retention requirements for the pharmaceutical industry.
• Extensive experience working in clinical electronic systems.
• 1+ years of experience working with clinical trial documentation.
• Understanding of ICH/GCP guidelines.
• Extensive knowledge of Microsoft Office products, web-based applications, and Adobe Acrobat Standard, plus the ability to apply related knowledge regarding scanning and other software programs.
• Innovate and Change.
• Pursue Scientific and Process Excellence.
• Work with Others.
• Achieve Results.
• Ability to work independently.
• Excellent interpersonal skills.

Physical Demands/Work Environment:

• General office environment.
• Physical lifting of boxes up to 25 lbs.
• Travel Requirements:
• % of time: 5%
• % of the above that requires overnight stay: 5%
• Travel is primarily to where: Other Fortrea locations, client, and vendor locations.

Learn more about our EEO & Accommodations request here.