Clinical Operations Delivery Associate

Thermo Fisher Scientific•Georgia - Remote, GA

6d•Onsite

About The Position

At Thermo Fisher Scientific, our mission is to enable our customers to make the world healthier, cleaner, and safer. Over the past five years, we have supported the world's top 50 pharmaceutical companies and more than 750 biotechnology organizations, contributing to over 2,700 clinical trials across 100+ countries. As a Senior Clinical Trial Coordinator, you'll play a key role in supporting the successful delivery of global clinical trials by providing administrative and technical expertise to project teams. You'll coordinate study activities, collaborate across multiple functions, and help ensure projects are delivered efficiently, compliantly, and to the highest quality standards. You'll also have the opportunity to mentor new colleagues and contribute to process improvement initiatives that drive operational excellence. What You'll Do As a Senior Clinical Trial Coordinator, you will provide operational support across multiple clinical studies while serving as a key point of coordination between project teams, investigators, vendors, and internal stakeholders.

Requirements

High school diploma or equivalent required.
Approximately 4+ years of experience in clinical research, clinical operations, or clinical trial coordination.
Equivalent combinations of education, training, and relevant experience will also be considered.

Nice To Haves

Bachelor's degree preferred.
Strong organizational skills with exceptional attention to detail.
Ability to manage multiple priorities in a fast-paced environment.
Excellent analytical and problem-solving abilities.
Strong customer service mindset and collaborative approach.
Good understanding of ICH-GCP, applicable country regulations, and clinical research processes.
Excellent English communication skills, both written and verbal; local language proficiency as required.
Strong presentation and interpersonal skills.
Proficiency with Microsoft Office (Word, Excel, PowerPoint) and the ability to quickly learn clinical trial management systems.
Experience with eTMF, GoBalto, or similar clinical systems is an advantage.
Self-motivated, adaptable, and able to work both independently and collaboratively.
Commitment to continuous learning and professional development.

Responsibilities

Coordinate and oversee assigned clinical trial activities in accordance with project requirements.
Ensure assigned tasks are completed on time, within budget, and to the highest quality standards.
Support the maintenance of study documentation, trackers, training records, and system access.
Maintain accurate and inspection-ready electronic Trial Master Files (eTMF) through regular reviews and quality checks.
Provide support for clinical systems such as eTMF, GoBalto, and other study management platforms.
Assist with Risk-Based Monitoring (RBM) activities.
Perform study administration tasks, including document processing, communications, reporting, and mass mailings.
Organize internal and client meetings, prepare agendas, and document meeting minutes.
Review, track, and coordinate local regulatory documentation and submissions.
Support document submissions to clients and central Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs).
Analyze study metrics and assist with the resolution of documentation findings.
Maintain vendor trackers and support vendor coordination activities.
Coordinate the preparation and distribution of Investigator Site Files (ISF), pharmacy binders, and study supplies.
Support translation activities and quality control reviews where required.
Participate in study start-up meetings and support project onboarding activities.
Mentor and provide guidance to new team members during onboarding.