Indianapolis, Indiana, United States of America
5 hours ago
Global Records Mgmt Associate - FSP

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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.

Division Specific Information

Our global Clinical Research Group (CRG) colleagues within the Functional Service Partnership (FSP) solutions area provide support for clinical trials during feasibility, study start up, maintenance, close out, and database lock, depending on the client’s needs. In this client dedicated role, you will work on-site to provide administrative and technical support by performing day-to-day functions within the client organization to support clinical trial activities.

A Day in the Life:

Administrative type position that manages the Records Center’s incoming/outgoing documents and files. The position is full-time and requires multi-tasking, communication and organizational skills, along with attention to detail. Position requires the ability to follow written and verbal instructions, the ability to lift 40lb boxes and the ability to be mobile. Some project work will be required in addition to Record Center responsibilities at times.

The ideal candidate possesses global experience within clinical research, clinical trials, or the pharmaceutical industry.

Location: Greenwood, Indiana. Relocation assistance is not available.

Responsibilities:

Handle incoming/outgoing research source documents (submissions or retrievals).Create and maintain document trackers for each process.Process electronic documents – move from one electronic storage area to another.Process paper documents to electronic and upload into proper system.Retrieve source documents from Central Study Coordinators.Process, sort, and file documents according to procedures.Review and verify source documents have been appropriately loaded to study-defined document repository and true-copy certified.Perform quality control on incoming documents and maintain data integrity on all documents.Make decisions on daily prioritization of work.Collaborate cross-functionally to execute the source document management process.

Keys to Success:

Education

High/Secondary school diploma or equivalent and relevant formal academic/vocational qualification.

Experience

Computer knowledge required.Microsoft Word and Excel knowledge.Records Management or similar background.Effective communication (both verbal and written) and language skills.Attention to detail.Research experience (preferred).Problem-solving skills.Self-management and organizational skills.Flexibility and adaptability.Knowledgeable of Good Clinical Practice (GCP)/Good Documentation Practice (GDP) (preferred).

Physical Requirements/Working 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 comprehensive and reasonable manner.Able to work upright and stationary for typical working hours.Ability to use and learn standard office equipment and technology with proficiency.Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.Travel may be required based on client needs.

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