Thermo Fisher Scientific

Principal Clinical Trial Coordinator - FSP

Thermo Fisher Scientific • $100K — $120K *
US-AnywhereRemote in North Carolina, US
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree preferred.
  • 5+ years of relevant experience in clinical project coordination.
  • Proficient in managing eTMF and clinical documentation processes.
  • Strong organizational and multitasking abilities.
  • Experience with project financial management and compliance tracking.

Responsibilities

  • Attend kick-off meetings and provide support during training for stakeholders.
  • Serve as eTMF lead and manage client integrations and activities.
  • Provide technical and administrative support for project coordination.
  • Assist with the preparation and review of study packages.
  • Support study close-out activities, including document reviews and certification.
  • Maintain communication among team members and manage project logistics.
  • Analyze study metrics and assist with submission activities.

Benefits

  • Opportunities for professional development and training.
  • Supportive team environment focused on collaboration.
  • Access to advanced technology and tools.
  • Engagement with varied therapeutic areas to expand knowledge.
Full Job Description
Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Summary of Essential Functions:
  • Attends kick-off meetings and supports training to team members, investigators, or clients as needed.
  • Serves as study eTMF lead, handling client integration and (e)TMF activities.
  • Provides technical and administrative support for project coordination to meet study-level milestone targets.
  • Assists with preparation and review of EDP/RCR packages.
  • Supports development of country or site-specific documents.
  • Support study close-out activities including final TMF Review and TMF certification form (DEV-FORM-1939) completion.
  • Support with preparations for Investigator Meetings
  • Maintaining and coordinating the logistical aspects of clinical projects and provide overall support to functional leads to ensure the successful completion of project deliverables.
  • Initiates the preparation of all project/program plans required by client contracts by reviewing contract and communicating with functional area leads.
  • Coordinates project/program/protocol specific and therapeutic area training needs. Tracks and follows up on all training, non-disclosure agreements, and security clearance requests.
  • Performs basic project financial management tasks as assigned.
  • Acts as task order/work assignment lead on small scopes of work for contracts/projects of low complexity.
  • Escalates compliance to established project-specific parameters and client expectations.
  • As Project Specialists ensures the contracted services and expectations of assigned projects are carried out by the project teams in accordance with executed contracts and the customers' requirements.
  • Maintaining timely and effective communication among team members, site staff and providing support for quality assurance activities, including preparation for audits and internal review, preparing documentation and follow through to resolution.
  • Maintenance and tracking of SOPs, client directives, and regulatory guidelines at the project level.
  • Contributes to discussions with teammates to support collaboration and best practices.
  • Expands therapeutic knowledge and expertise.


In addition to tasks listed above essential functions will include tasks below with increased skill level and years of experience above Principal CTC.
  • Develops site list and ensures contact details are maintained in Client/PPD systems including Veeva.
  • Provides admin and technical support to study management and program teams, including:
    • Supports meeting scheduling, minute taking, document creation and transmission.
    • May maintain vendor trackers.
    • Works with sites to obtain relevant documents.
    • Completes site interest plan and documents site communications.
    • Works directly with sites to obtain site qualification, selection and start-up documents.
    • Works with CSO to develop the site list and ensures contact details are maintained in Client/PPD systems including Veeva.


  • Performs document processing and follow-up tasks, including:
    • Initial quality checks of eTMF documents, file reviews, and documents findings.
    • Request eTraining report reviews to begin on a quarterly basis
    • Performs file reviews and documents findings in appropriate system, including tracking local regulatory documents.
    • Supports maintenance of study-specific documentation and global systems/tools.
    • May conduct quarterly eTMF completeness checks.


  • Coordinates and completes assigned activities ensuring proactive scheduling and fulfillment, aligned with project team needs, including:
    • Provides system access (e.g., Veeva & eTMF) and inputting site and study information into current databases and generating reports.
    • Analyzes and reconcile study metrics and findings reports, clarifying and resolving issues related to site documentation.
    • Assists with coordination, compilation, and distribution of Investigator Site File (ISF) and supplies to sites.
    • May maintain vendor trackers.
    • Ensures efficient site contact and follow-up plan, escalating concerns as needed.


  • Assists with Study Start-up and ongoing submission activities as needed
    • Transmits documents to centralized IRB/IEC (on-going).
    • Request insurance in each country
    • Coordinates with key QSDO functions to align site start-up activities.
    • May support study-specific translation of materials and QC.
    • May be requested to help with checking if CDAs exist/are expired & obtaining a new Inv/Institution CDA.
    • May work with the CTT Representative, to provide relevant study information


  • Other essential tasks and principal duties:
    • Supports survey data review and collaboration with teammates.
    • May liaise and contributes to feasibility processes.
    • Compliant with general and study specific training, ensuring knowledge of relevant SOPs and regulatory guidance.
    • Contributes to the development of best practices.


Education and Experience:
• Bachelor's degree preferred.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ 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.

About Thermo Fisher Scientific

Thermo Fisher Scientific Careers

Join the vibrant team at Thermo Fisher Scientific, a global leader in serving science and making the world healthier, cleaner, and safer. With a workforce of over 75,000 professionals, Thermo Fisher Scientific offers unparalleled job opportunities and a culture of innovation that propels your career to new heights. Work You’ll Do At Thermo Fisher Scientific, you will be part of a team that is dedicated to enabling our customers to make the world healthier. Whether you are involved in the development of life-saving drugs or innovative environmental solutions, your work will have a profound impact on society. Our commitment to leadership in the industry is unwavering. With Thermo Fisher Scientific, you will lead projects that set standards in scientific inquiry and market leadership. You will work at the intersection of science, technology, and industry expertise, driving digital innovation in every aspect of our business. Join our diverse team of professionals and engage in roles that span across various functions and disciplines. From research and development to marketing and sales, the breadth of job opportunities available means that you can find the perfect match for your skills and passions. Innovative Work As part of our team, you will have access to cutting-edge tools and technologies that foster creativity and innovation. Thermo Fisher Scientific is home to a dynamic range of career paths, all designed to challenge you and help you grow as a professional. Our employment philosophy emphasizes diversity and inclusivity, ensuring that all team members have the opportunity to thrive. We believe in nurturing talent through robust training programs, leadership development, and opportunities for career advancement. Be Part of a Great Team Working at Thermo Fisher Scientific means being part of a global network of enthusiastic, talented, and ambitious individuals. Our culture is built on collaboration, where each member’s unique skills and perspectives are valued. You will enjoy benefits that support both your professional growth and personal well-being. Future-Proof Your Career Embark on a journey of growth and continuous learning with Thermo Fisher Scientific. We offer a variety of training and development programs that cater to your interests and career goals. From internships for budding scientists to leadership training for aspiring executives, our programs are designed to equip you with the skills needed for a successful and fulfilling career. Explore Discover how our commitment to innovation leads to advancements in health and science: [Read More] Learn about our leadership in environmental sustainability and how you can contribute: [Read More] The Thermo Fisher Scientific Difference Our global presence and commitment to innovation mean that your work extends beyond borders and makes a tangible impact worldwide. The collaboration between our teams drives our leadership in the scientific community and contributes to a culture that embraces diversity and fosters professional growth. Stay Connected Join Our Team Search open positions that match your skills and interest. We are always on the lookout for passionate, curious, and driven team players. Explore our job opportunities and find out how you can contribute to our meaningful work. SEARCH THERMO FISHER SCIENTIFIC JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Customize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Thermo Fisher Scientific.
Learn more about Thermo Fisher Scientific
Size
130,000 employees
Market Cap
$213.3 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.3 billion
Founded
1956
5 Year Trend
+16.5%
Revenue
$32.2 billion
NASDAQ
TMO
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Thermo Fisher Scientific

More Pharmaceuticals & Biotech Jobs

Find similar Principal Clinical Trial Coordinator - FSP jobs:

NationwideRemote