Top 26 Clinical documentation specialist Jobs in Charlotte, Nc

FSP Country Approval Specialist
Thermo Fisher Scientific —North Carolina
- Full-time
- Remote
- Computer literacy
- English
- Mid-level
11d
Clinician Coding Liaison - New Clinician Onboarding Specialist
Atrium Health —Charlotte, NC
- $35.50 - $53.25 an hour
- Full-time
- Remote
- Anatomy knowledge
- High school diploma or GED
- Analysis skills
- Paid parental leave
- Disability insurance
4d
Clinical Document Integrity Specialist - Part Time - Remote
Duke Health —Mooresville, NC
- Part-time
- Remote
- Nursing
- Doctoral degree
- RN License
- Relocation assistance
Billing Specialist - Part Time
Hope Haven, Inc. —Charlotte, NC
- $18 - $23 an hour
- Part-time
- HIPAA
- Associate's degree
- Entry level
Revenue Cycle Specialist
Mcleod Centers for Wellbeing —Charlotte, NC
- $19.50 - $21.25 an hour
- Full-time
- Hybrid work
- Research
- Mid-level
- Office
- Paid jury duty
- Health savings account
Quick Apply
Patient Recruitment Specialist
Flourish Research —Charlotte, NC
- $27 - $30 a year
- Weekends as needed
- HIPAA
- 3 years
- High school diploma or GED
- Paid holidays
- Disability insurance
Quick Apply
14d
Oncology Research Specialist Registered Nurse - Atrium Health Levine Cancer Institute Clinical Trials
Atrium Health —Charlotte, NC
- $38.20 - $57.30 an hour
- Full-time
- CPR Certification
- Nursing
- RN License
- Paid parental leave
- Disability insurance
2d
Regional Clinical Reimbursement Consultant – State Veterans Homes
STG International, Inc. —Charlotte, NC
- Nursing
- Skilled nursing facility
- RN License
- Health insurance
- Dental insurance
Quick Apply
Primary and Palliative Care Nurse - RN/LPN PRN
VIA Health Partners —Charlotte, NC
- PRN
- CPR Certification
- Nursing
- RN License
Quick Apply
10d
Primary and Palliative Care Registered Nurse (RN) or LPN PRN
VIA Health Partners —Charlotte, NC
- Full-time
- CPR Certification
- Nursing
- RN License
Quick Apply
Registered Nurse RN Outpatient Clinical Care Specialist
Ascend Health and Wellness —Mooresville, NC
- $78,000 - $84,000 a year
- Full-time
- RN License
- Mid-level
- Outpatient experience
- Paid holidays
- Disability insurance
Quick Apply
24/7 Registered Nurse
United Energy Workers Healthcare —Charlotte, NC
- $6,720 a week
- Background check
- Nursing
- RN License
Registered Nurse
ROOF ABOVE INC —Charlotte, NC
- Nursing
- Vital signs
- RN License
Staff RN - ECMO Spec / FT, nights
Children's Nebraska —United States
- Overtime
- Nursing
- RN License
- BLS Certification
- Flexible schedule
Staff RN - ECMO Spec / FT, D/N
Children's Nebraska —United States
- Overtime
- Nursing
- RN License
- BLS Certification
- Flexible schedule
Travel PCU RN in Memphis, Tennessee
GIFTED Healthcare —United States
- $2,043.40 - $2,135.99 a week
- Overtime
- Nursing
- RN License
- BLS Certification
- Health insurance
- Dental insurance
Quick Apply
3d
Travel IMC RN Job in Birmingham, Alabama
GIFTED Healthcare —United States
- $2,122.06 - $2,242.62 a week
- Overtime
- Nursing
- Medication administration
- RN License
- Health insurance
- Dental insurance
Quick Apply

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FSP Country Approval Specialist

Thermo Fisher Scientific -
North Carolina

Apply Now

Job Details

Full-time
11 days ago

Qualifications

Computer literacy

Full Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Country Approval Specialist – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, 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 participate in the management and preparation, review, and coordination of Country Submissions in line with the global submission strategy. As a Country Approval Specialist, you'll play a key role in ensuring that submissions are managed effectively and align with our strategic goals.

What You’ll Do:

Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients.
Provides project specific local SIA services and coordination of these projects.
May have contact with investigators for submission related activities.
Key-contact at country level for either Ethical or Regulatory submission-related activities.
Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
Achieves PPD’s target cycle times for site.
May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
May develop country specific Patient Information Sheet/Informed Consent form documents.
May assist with grant budgets(s) and payment schedules negotiations with sites.
Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
Entes and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner.
Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Education and Experience Requirements:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

Previous Contract Research Organization (CRO) experience is highly preferred.

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.

Knowledge, Skills and Abilities:

Effective oral and written communication skills
Excellent interpersonal skills
Strong attention to detail and quality of documentation
Good negotiation skills
Good computer skills and the ability to learn appropriate software
Good English language and grammar skills
Basic medical/therapeutic area and medical terminology knowledge
Ability to work in a team environment or independently, under direction, as required
Basic organizational and planning skills
Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations

Working Conditions and Environment:

Work is performed in an office/ laboratory and/or a clinical environment.
Exposure to biological fluids with potential exposure to infectious organisms.
Exposure to electrical office equipment.
Personal protective equipment required such as protective eyewear, garments and gloves

Apply Now

Refine Your Search

clinical documentation specialist jobs in charlotte, nc

FSP Country Approval Specialist

Clinician Coding Liaison - New Clinician Onboarding Specialist

Clinical Document Integrity Specialist - Part Time - Remote

Billing Specialist - Part Time

Revenue Cycle Specialist

Patient Recruitment Specialist

Oncology Research Specialist Registered Nurse - Atrium Health Levine Cancer Institute Clinical Trials

Regional Clinical Reimbursement Consultant – State Veterans Homes

Primary and Palliative Care Nurse - RN/LPN PRN

Primary and Palliative Care Registered Nurse (RN) or LPN PRN

Registered Nurse RN Outpatient Clinical Care Specialist

24/7 Registered Nurse

Registered Nurse

Staff RN - ECMO Spec / FT, nights

Staff RN - ECMO Spec / FT, D/N

Travel PCU RN in Memphis, Tennessee

Travel IMC RN Job in Birmingham, Alabama

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