Top 34 Clinical research associate Jobs in Charlotte, Nc

Country Approval Specialist - FSP
Thermo Fisher Scientific —North Carolina
- Full-time
- Remote
- English
- Mid-level
- Office
Clinical Research Coordinator I or II
OnSite Clinical Solutions, LLC —Charlotte, NC
- $22 - $32 an hour
- Full-time
- Background check
- Computer literacy
- Organizational skills
- Health insurance
- Dental insurance
Quick Apply
4d
Clinical Research Coordinator (Charlotte, NC)
SiteBridge Research, Inc. —Charlotte, NC
- $30 - $36 an hour
- Part-time
- Spanish
- Mid-level
- 3 years
Quick Apply
Oncology Research Specialist - Pediatrics
Atrium Health —Charlotte, NC
- $25.30 - $37.95 an hour
- Full-time
- English
- Mid-level
- Office
- Paid parental leave
- Disability insurance
Clinical Research Coordinator
OrthoCarolina —Charlotte, NC
- Full-time
- Word processing
- Bachelor of Science
- English
- Profit sharing
- Wellness program
Quick Apply
1d
Data Coordinator Neurosciences Institute Research (GCA)
Atrium Health —Charlotte, NC
- $21.85 - $32.80 an hour
- Part-time
- Computer science
- Computer Science
- Word processing
- Paid parental leave
- Disability insurance
4d
Clinical Research Coordinator
DelRicht Research —Huntersville, NC
- Full-time
- Blood sampling
- Urgent Care
- Clinic experience
- Profit sharing
- Disability insurance
Clinical Research Coordinator
Joint and Muscle Medical Care —Charlotte, NC
- $25 an hour
- Full-time
- Management
- Mid-level
- Bachelor's degree
- Health insurance
- Paid time off
Quick Apply
12d
Clinical Research Coordinator
Flourish Research —Charlotte, NC
- $28 - $34 a year
- Full-time
- Vital signs
- HIPAA
- Mid-level
- Paid holidays
- Disability insurance
Quick Apply
Clinical Research Nurse - AH Levine Children's Vaccine Trials - FT Day
Atrium Health —Charlotte, NC
- $38.20 - $57.30 an hour
- Full-time
- Spanish
- Nursing
- RN License
- Paid parental leave
- Disability insurance
Oncology Research Specialist Registered Nurse
Atrium Health —Charlotte, NC
- $38.20 - $57.30 an hour
- Full-time
- CPR Certification
- Nursing
- RN License
- Paid parental leave
- Disability insurance
6d
Data Entry Coordinator
Joint and Muscle Medical Care —Charlotte, NC
- $17 an hour
- Full-time
- Mid-level
- Continuous improvement
- Associate's degree
- Health insurance
- Paid time off
Quick Apply
12d
Research Technician - PHHI
North Carolina State University —Kannapolis, NC
- $34,320 - $49,000 a year
- Full-time
- CPR Certification
- First Aid Certification
- US work authorization
- Paid holidays
- Disability insurance
Clinical Laboratory Assistant - Atrium Health Charlotte FT
Atrium Health —Charlotte, NC
- $19.80 - $29.70 an hour
- Full-time
- Hospital
- Computer literacy
- High school diploma or GED
- Paid parental leave
- Disability insurance
13d
Clinical Laboratory Assistant - Atrium Health Charlotte(PRN) every other weekend
Atrium Health —Charlotte, NC
- $19.80 - $29.70 an hour
- Part-time
- Hospital
- Computer literacy
- High school diploma or GED
- Paid parental leave
- Disability insurance
Clinical Lab Assistant - Atrium Health Mercy PT Weekends 3rd Shift
Atrium Health —Charlotte, NC
- $19.80 - $29.70 an hour
- Part-time
- Hospital
- Computer literacy
- High school diploma or GED
- Paid parental leave
- Disability insurance
Clinical Laboratory Assistant - Atrium Health Charlotte FT Nights
Atrium Health —Charlotte, NC
- $19.80 - $29.70 an hour
- Full-time
- Hospital
- Computer literacy
- High school diploma or GED
- Paid parental leave
- Disability insurance
4d
Registered Nurse Program Coordinator - Pediatric Clinical Research
Atrium Health —Charlotte, NC
- $38.20 - $57.30 an hour
- Full-time
- Nursing
- RN License
- Ability to walk for extended periods
- Paid parental leave
- Disability insurance
Director of Study Operations
START Center for Cancer Research —Charlotte, NC
- Monday to Friday
- Nursing
- 5 years
- BLS Certification
- Health savings account
- Paid holidays
Quick Apply
5d
Licensed Practical Nurse LPN - Research Assistant
Joint and Muscle Medical Care —Charlotte, NC
- $25 an hour
- Full-time
- CPR Certification
- Nursing
- Patient monitoring
- Paid holidays
- Health insurance
Quick Apply

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Country Approval Specialist - FSP

Thermo Fisher Scientific -
North Carolina

Apply Now

Job Details

Full-time

Qualifications

FDA submissions
Critical path method
Informed consent
Document control experience within pharmaceutical industry
Drug regulation
English
Mid-level
Clinical research protocol review
Bachelor's degree
Quality control
Informed consent procedures implementation
Clinical trial standard operating procedures
Regulatory submission editing and review
Communication with regulatory authorities for clinical trials
Computer skills
Clinical trial site selection
Clinical consent forms
Ethical review application preparation
Grammar Experience
Standard operating procedures (SOPs)
Medical terminology
Communication skills
Negotiation

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 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 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:

Prepare, review, and coordinate local regulatory submissions (EC, additional special national local applications if applicable, e.g. therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy for the initial application and amendments as necessary.
Provide local regulatory strategy advice (RA &/or EC) to key stakeholders.
Provide local submission strategy for their country in consultation with regional oversight lead and key team members.
Provide technical expertise and coordination oversight for study in collaboration with relevant stakeholders.
Serve as primary contact for investigators and with the local regulatory authorities and ethics committees (in collaboration with their People Manager for complex issues) to ensure submissions are managed in a timely manner.
Serve as a key contact at the country level for submission-related activities and ensure guidelines and processes are followed for effective communications with study teams, investigators, and RAs and ECs to ensure submissions are managed in a timely manner.
May identify issues or anomalies in the regulatory process of a study and escalate as appropriate.
May support country specific Informed Consent Form (ICF) negotiations with EC/IRB or RA and raise any country-level ICF risks to Informed Consent Manager (ICM) and study leadership.
Develop site-specific ICFs manage ICF negotiations with EC/IRB, and document site ICF approvals.
Adapt country and site specific ICF changes for protocol and Investigator Brochure (IB) amendments as necessary.
Coordinate with key stakeholders to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are aligned to the critical path for site activation.
Align with the site on the critical start-up path upon site selection and take accountability for maintaining accurate tracking of the site’s critical path throughout the start-up phase.
Achieve set baseline cycle times for site activation.
Responsible for Essential Documents (ED) creation, collection and QC.
May prepare Essential Document Packs (EDPs).
If required for the study, support the coordination of feasibility activities, in accordance with agreed timelines.
Ensure that trial status information relating to start-up activities is accurately maintained in the database and is always current.
Ensure current investigator and site staff contact details are appropriately maintained in systems.
Ensure TMF is current for country and sites according to sponsor SOPs.
Maintains knowledge of and understand PPD SOPs, sponsor SOPs/directives, and current regulatory guidelines as applicable to services provided.
Complete handover document and provide to Site Manager at the appropriate point – which will be study dependent.
Participate as required in Team Meetings.
May be required to support activation readiness at the site level to ensure training completion, system access, and supplies are onsite.

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).

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.

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.

Apply Now

Refine Your Search

clinical research associate jobs in charlotte, nc

Country Approval Specialist - FSP

Clinical Research Coordinator I or II

Clinical Research Coordinator (Charlotte, NC)

Oncology Research Specialist - Pediatrics

Clinical Research Coordinator

Data Coordinator Neurosciences Institute Research (GCA)

Clinical Research Coordinator

Clinical Research Coordinator

Clinical Research Coordinator

Clinical Research Nurse - AH Levine Children's Vaccine Trials - FT Day

Oncology Research Specialist Registered Nurse

Data Entry Coordinator

Research Technician - PHHI

Clinical Laboratory Assistant - Atrium Health Charlotte FT

Clinical Laboratory Assistant - Atrium Health Charlotte(PRN) every other weekend

Clinical Lab Assistant - Atrium Health Mercy PT Weekends 3rd Shift

Clinical Laboratory Assistant - Atrium Health Charlotte FT Nights

Registered Nurse Program Coordinator - Pediatric Clinical Research

Director of Study Operations

Licensed Practical Nurse LPN - Research Assistant

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