Records Specialist

This is a fully onsite role supporting our BIOA Lab in Richmond, VA. We welcome applicants from all locations within the US. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening.

About the Role

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life—enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.

Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

Responsibilities

• Process (scans/images, indexes, files) incoming study documents (paper and/or electronic).
• Assist clinical study teams as required per WPD/SOP with filing of all documents for the trial master file (TMF/eTMF) and case report forms (CRF).
• Act as the study team subject matter expert on the filing process for assigned studies.
• Liaise with the clinical study team to resolve outstanding issues identified during filing and/or quality reviews.
• Provide extensive technical support for the study team when initiating the TMF.
• Maintain and update products and systems associated with global records classification, retention and disposition.
• Conduct training for department staff, company employees, and clients.
• Assist with applicable sponsor deliverables.
• Work independently on special projects.

Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
• Associate's degree preferred.
• Technical positions may require a certificate.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Skills

• Sophisticated communication and interpersonal skills.
• Excellent organizational skills and strong attention to detail with proven ability to handle multiple tasks efficiently and effectively.
• Ability to effectively analyze project specific data/systems to ensure accuracy and efficiency.
• Flexibility to reprioritize workload to meet changing project timelines.
• Firm understanding of applicable systems including document management software and the eTMF.
• Advanced computer skills.
• Excellent English and grammar skills (second language a plus).

Schedule

First Shift (Days).

Environmental Conditions

• Able to lift 40 lbs. without assistance.
• Office, Warehouse.
• Work is performed in an office or clinical environment with exposure to electrical office equipment.
• Travel as required by special projects and supervisor needs.
• Long, varied hours required on occasion.