Top 1639 Clinical documentation Jobs in Raleigh, 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
QA Systems Specialist
Kelly Services —Raleigh, NC
- $76,000 - $110,000 a year
- Overtime
- Microsoft Excel
- Microsoft Outlook
- 5 years
- Paid holidays
- Disability insurance
Quick Apply
11d
Clinical Service Evaluator II (Full-Time Remote, North Carolina Based)
Alliance Health —Morrisville, NC
- $61,439 - $79,871 a year
- Full-time
- Remote
- Microsoft Access
- 5 years
- Mid-level
- Disability insurance
- Health insurance
HEDIS Clinical Quality Analyst (Full Time, Remote, North Carolina Based)
Alliance Health —Morrisville, NC
- $79,425 - $101,267 a year
- Full-time
- Remote
- Microsoft Word
- Nursing
- RN License
- Disability insurance
- Health insurance
Clinical Documentation Specialist
Singing River Health System —Raleigh, NC
- Weekends as needed
- Remote
- Nursing
- Microsoft Outlook
- RN License
Quick Apply
Systems Analyst II, Epic Clinical
WakeMed Health & Hospitals —Raleigh, NC
- Full-time
- Research
- Mid-level
- 3 years
Clinical Quality Assurance Specialist - Bone Marrow Transplant Program
UNC Health —Chapel Hill, NC
- $35.87 - $51.57 an hour
- Full-time
- Hybrid work
- Nursing
- RN License
- Mid-level
MRI Technologist-Hospital
WakeMed Health & Hospitals —Raleigh, NC
- Full-time
- Patient monitoring
- Hospital
- Mid-level
13d
MRI Technologist-Hospital
WakeMed Health & Hospitals —Raleigh, NC
- Patient monitoring
- Hospital
- Mid-level
Outpatient Therapist
B&D Integrated Health Services —Durham, NC
- $40 - $80 an hour
- Full-time
- Hybrid work
- Background check
- Licensed Clinical Social Worker
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
Radiology Technologist
WakeMed Health & Hospitals —Raleigh, NC
- Full-time
- Patient monitoring
- Inpatient
- Mid-level
LCAS,LCMHC,LCSW
Integrated Care for Greater Health, Inc —Raleigh, NC
- 8 hour shift
- Addiction Medicine
- Licensed Clinical Social Worker
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
12d
Board Certified Behavior Analyst -Sign on Bonus Offered- North Carolina (BCBA)
Apex ABA Therapy —Raleigh, NC
- $90,000 - $100,000 a year
- Part-time
- Writing skills
- Mid-level
- Experience working with children
- Dental insurance
- Paid time off
Quick Apply
Sonographer, FT Flex, Outpatient
Cardinal Points Imaging of the Carolinas - Raleigh, NC —Raleigh, NC
- Full-time
- Anatomy knowledge
- 5 years
- Outpatient experience
Quick Apply
13d
MRI Technologist, Full-Time Flex, Outpatient
Cardinal Points Imaging of the Carolinas - Raleigh, NC —Raleigh, NC
- 12 hour shift
- Anatomy knowledge
- Customer service
- Mid-level
- Health savings account
- Paid holidays
Quick Apply
3d
Clinical Psychologist
Matrix Providers —North Carolina
- $55.00 - $60.07 an hour
- Full-time
- Psychiatry
- Mid-level
- Neurology
- Paid holidays
- Health insurance
Quick Apply
Board Certified Behavior Analyst (BCBA)
JoyBridge Kids —Raleigh-Durham, NC
- Part-time
- Mid-level
- Master's degree
- Clinic
- Continuing education credits
- Health savings account
Quick Apply
13d
Hybrid Board Certified Behavior Analyst (BCBA/BCaBA/QBA) Full Time/Part Time
Bee Wise Behavior —Durham, NC
- $70,000 - $110,000 a year
- Part-time
- Hybrid work
- Experience working with individuals with developmental disabilities
- Applied behavior analysis
- HIPAA
- Continuing education credits
- Mileage reimbursement
Quick Apply
3d
Respiratory Therapist, Registered
WakeMed Health & Hospitals —Cary, NC
- PALS Certification
- Hospital
- BLS Certification
- Free parking
- Dental insurance
10d
Board Certified Behavior Analyst (BCBA)
JoyBridge Kids —Durham, NC
- Part-time
- Mid-level
- Master's degree
- Clinic
- Health savings account
- Paid holidays
Quick Apply

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clinical documentation jobs near raleigh, nc

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

Thermo Fisher Scientific -
North Carolina

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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.

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Refine Your Search

clinical documentation jobs in raleigh, nc

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

QA Systems Specialist

Clinical Service Evaluator II (Full-Time Remote, North Carolina Based)

HEDIS Clinical Quality Analyst (Full Time, Remote, North Carolina Based)

Clinical Documentation Specialist

Systems Analyst II, Epic Clinical

Clinical Quality Assurance Specialist - Bone Marrow Transplant Program

MRI Technologist-Hospital

MRI Technologist-Hospital

Outpatient Therapist

Radiology Technologist

LCAS,LCMHC,LCSW

Board Certified Behavior Analyst -Sign on Bonus Offered- North Carolina (BCBA)

Sonographer, FT Flex, Outpatient

MRI Technologist, Full-Time Flex, Outpatient

Clinical Psychologist

Board Certified Behavior Analyst (BCBA)

Hybrid Board Certified Behavior Analyst (BCBA/BCaBA/QBA) Full Time/Part Time

Respiratory Therapist, Registered

Board Certified Behavior Analyst (BCBA)

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