Top 19 Clinical research Jobs in Jacksonville, Nc

Essential Document Pack (EDP) Reviewer - Clinical Trials - FSP
Thermo Fisher Scientific —North Carolina
- $93,000 - $125,000 a year
- Full-time
- Remote
- Microsoft Excel
- English
- Mid-level
3d
Principal Clinical Trial Coordinator - FSP
Thermo Fisher Scientific —North Carolina
- Full-time
- Remote
- Office
- Bachelor's degree
- Team management
Country Approval Specialist - FSP
Thermo Fisher Scientific —North Carolina
- Full-time
- Remote
- English
- Mid-level
- Office
Research Coordinator
Bering-Alaka`ina Holdings, LLC —Jacksonville, NC
- Word processing
- Computer literacy
- HIPAA
- Paid holidays
- Disability insurance
CNA II - POD Assistant
Southeastern Medical Oncology Center —Jacksonville, NC
- 8 hour shift
- Mid-level
- In-person
- CNA
- Disability insurance
- Health insurance
Quick Apply
7d
Certified Nursing Assistant, POD
Southeastern Medical Oncology Center —Jacksonville, NC
- 8 hour shift
- Mid-level
- In-person
- CNA
- Disability insurance
- Health insurance
Quick Apply
7d
HL7 Data Analyst
VITL —United States
- $110,000 - $115,000 a year
- Email
- 5 years
- Salesforce
- Mid-level
- Health savings account
- Disability insurance
Quick Apply
4d
Special Agent: Healthcare Services/Medical Background
Federal Bureau of Investigation —United States
- $103,326 - $133,200 a year
- Full-time
- Mid-level
- Bachelor's degree
- Travel
14d

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A valid driver’s license is required for travel. NC driver’s license required within 60 days of hire and must be maintained.
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Essential Document Pack (EDP) Reviewer - Clinical Trials - FSP

Thermo Fisher Scientific -
North Carolina

Apply Now

Job Details

Full-time
$93,000 - $125,000 a year
3 days ago

Qualifications

Microsoft Excel
Clinical compliance checks
English
Research compliance clinical trial records management
Document quality checks
Productivity software
Clinical quality assurance standards
Quality control communication
Regulatory compliance analysis
Standard operating procedures (SOPs)

Full Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Summary of Essential Functions:

Essential Document Pack (EDP) reviewer is responsible for the review and approval of the country and site essential documents. The EDP contains at a minimum the most critical essential documents required for site activation. The documents required to be collected for each study site/country will be documented in a study-specific Essential Document Compliance (EDC) Review Checklist. Once final study documents are available, the EDP is reviewed for all required essential regulatory documents for completeness, accuracy and quality. The packs are reviewed by designated EDP reviewers who are independent from the study.

Position Summary

The Essential Document Pack (EDP) Reviewer is responsible for the independent review of country- and site-level essential document packages required to support clinical trial site activation.

This is a hands-on clinical trial document review and compliance role. The EDP Reviewer assesses essential regulatory documents for completeness, accuracy, quality, and compliance with study-specific requirements, applicable SOPs, client requirements, and regulatory guidelines.

The strongest candidates will have direct experience reviewing clinical trial essential/regulatory documents, supporting study or site start-up, or working with regulatory documentation required for site activation.

Key Responsibilities

Independently review country-level essential documents for completeness, accuracy, quality, and compliance with the applicable Essential Document Compliance checklist.
Independently review site-level essential documents required for clinical trial site activation.
Confirm that required essential regulatory documentation is present and meets applicable study, sponsor, SOP, and regulatory requirements.
Identify documentation deficiencies, inconsistencies, missing information, or quality concerns.
Communicate review outcomes and required corrections to EDP submitters and/or appropriate study team members.
Review revised document packages to confirm identified deficiencies have been appropriately resolved.
Communicate final review outcomes to Study Start-Up Specialists and other applicable stakeholders.
Accurately track EDP review activities and outcomes in applicable systems and databases.
Maintain current knowledge of company SOPs, client SOPs and directives, study-specific requirements, and applicable regulatory guidelines.
Apply independent judgment when assessing whether clinical trial documentation meets established requirements.
Partner effectively with study teams to support timely and compliant site activation.

Minimum Qualifications

Bachelor's degree or equivalent combination of education and relevant experience.
2+ years of relevant clinical research experience, including hands-on experience with clinical trial regulatory or essential documentation.
Experience reviewing clinical trial documentation for completeness, accuracy, quality, and/or regulatory compliance.
Experience in one or more of the following areas:
- Clinical trial essential document review
- Study or site start-up
- Clinical regulatory documentation
- Site activation
- Regulatory start-up
- TMF/eTMF or equivalent clinical trial documentation
Working knowledge of SOPs, clinical trial documentation requirements, and applicable regulatory guidelines.
Ability to independently identify documentation deficiencies and communicate required corrections.
Strong attention to detail, quality, and document accuracy.
Strong written and verbal English communication skills; local language proficiency where applicable.
Ability to work independently, exercise sound judgment, and manage multiple priorities and timelines.
Strong analytical, investigative, and problem-solving skills.
Proficiency with Microsoft Word, Excel, and PowerPoint, with the ability to learn new systems and technologies.

Preferred Experience

Experience working within a CRO, pharmaceutical, biotechnology, or other clinical research environment.
Experience supporting multinational or country-level clinical trial start-up activities.
Familiarity with global, regional, and country-specific clinical trial regulatory requirements.
Experience reviewing Essential Document Packages, regulatory document checklists, or equivalent site activation documentation.
Familiarity with ICH-GCP and clinical trial regulatory requirements.
Experience communicating document deficiencies and working with study teams to achieve compliant deliverables.

Compensation

The estimated annualized pay range for this position in North Carolina is $93,000.00–$125,000.00.

Apply Now

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clinical research jobs in jacksonville, nc

Essential Document Pack (EDP) Reviewer - Clinical Trials - FSP

Principal Clinical Trial Coordinator - FSP

Country Approval Specialist - FSP

Research Coordinator

CNA II - POD Assistant

Certified Nursing Assistant, POD

HL7 Data Analyst

Special Agent: Healthcare Services/Medical Background

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