Records Specialist

Work Schedule

First Shift (Days)

Environmental Conditions

Able to lift 40 lbs. without assistance, Office

This is a fully onsite role based at our BioAnalytical Laboratory in Richmond, VA. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.

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.

The working schedule for this role is Monday - Friday from 8AM-5PM EST.

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. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Location/Division Specific Information

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

Discover Impactful Work

Provides general global records management (GRM) and file room support by working closely with global project teams to ensure all global records management tasks are completed according to organization and/or client standard operating procedures (SOP) and working practice documents (WPD), and provides broad technical assistance to study teams.

A Day in the Life

- Processes (scans/images, indexes, files) incoming study documents (paper and/or electronic).

- Assists 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).

- Acts as the study team subject matter expert on the filing process for assigned studies.

- Liaises with the clinical study team to resolve outstanding issues identified during filing and/or quality reviews.

- Provides extensive technical support for the study team when initiating the TMF.

- Maintains and updates products and systems associated with global records classification, retention and disposition.

- Conducts training for department staff, company employees, and clients.

- Assists with applicable sponsor deliverables.

- Works independently on special projects.

Keys to Success

Education and Experience:

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.

Knowledge, Skills and Abilities:

- 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)

Work Environment

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

• Able to work upright and stationary and/or standing for typical working hours. • Able to lift and move objects up to 25 pounds.

• Able to work in non-traditional work environments.

• Able to use and learn standard office equipment and technology with proficiency.

• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.

• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response