New · posted Nov 5
Thermo Fisher Scientific · Pharmaceuticals
FSP Clinical Trial Coordinator
- Remote, North Carolina
- Remote
- Full-time
- Associate & Specialist
The role
Join Us as a Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotech's, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you’ll have the opportunity to provide administrative and technical support to the Project Team. As a Clinical Trial Coord, you'll support audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. You will provide administrative support for site activation activities and aid in the development of the critical path for site activation within assigned projects to support rapid site activations. Representing CRG personnel, you may utilize local knowledge, organization systems, external site lists, and sponsor directives to develop and review site lists that are suitable for the strategic needs of feasibility activities and to provide local input into the site tiering process. Additionally, you may act as a buddy during the onboarding phase and provide training to new staff as needed.
What you need
Education and Experience Requirements
- A minimum of a High School Diploma or equivalent education (i.e., GED), relevant formal academic/vocational qualification, and at least one (1) year of relevant experience; or
- Bachelor's degree in a related field with 0+ years of experience.
Knowledge, Skills and Abilities
- Highly developed administrative skills, excellent document management and organizational skills
- Capable of managing multiple assignments and able to work independently
- Good understanding of project related priorities
- Strong verbal and written communication skills (cultural-sensitive, clear and transparent)
- Strong MS-Office skills (Excel, Word, Power Point, Outlook etc.)
- Knowledge of International Conference on Harmonization (ICH) regulations and Good Clinical Practice (GCP), Good Documentation Practice and local regulatory regulations
What you'll do
- Ensure timely availability of trial materials and respective documentation for setup and execution of clinical trials.
- Manage TMF and ISF, including proper setup, ongoing filing, and completeness prior to archiving.
- Manage clinical systems, ensuring accurate reporting, data completeness, and access management.
- Coordinate with suppliers to ensure site supplies, logistics, and import/export compliance.
- Support site activities (e.g., confidentiality agreements, feasibility questionnaires, system forms).
- Assist in site initiation readiness.
- Maintain tracking tools for operational oversight
- Coordinate site documentation to support timely site qualification and progression
Schedule and working conditions
Days
Standard (Mon-Fri)
Environmental Conditions
Office
Job intelligence
The context around this role
Live data · November 5, 2026
Salary intelligence
How the pay compares
Associate & Specialist roles in the US13 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $76,000 | $87,500 | $100,000 |
Comparisons: the base pay employers published on open Clinical Operations roles at the same level on Regulatory Jobs, November 5, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Operations
The general path across 103 open Clinical Operations roles on Regulatory Jobs, with the titles they carry most. Not Thermo Fisher's own promotion track.
Career resources on Clinical Operations
Skills DNA
What this role leans on
How many of the posting's 17 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs5
- Clinical trial conduct4
- GMP and compliance3
- Validation and qualification2
- Data and digital systems2
- Collaboration and leadership2
- Quality systems and risk1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Operations work in pharmaceuticals, led by the one this posting names, each linked to the agency or standards body that publishes it.
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
Company hiring pulse
Thermo Fisher on Regulatory Jobs
- 123
- Open roles
- 109
- Distinct roles
- 48
- Locations
By discipline
- Quality77 63%
- Clinical40 33%
- Regulatory6 5%
By level
- Senior & Principal52 42%
- Associate & Specialist38 31%
- Manager27 22%
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FSP Clinical Trial Coordinator at Thermo Fisher
Open until filled.