Clinical Research Associate
Location: Remote | Hybrid | Monroe, NC
Employment Type: Direct Hire
Travel: Up to 50% (car allowance, mileage reimbursement, and company purchase card provided)
Position Overview
We are seeking a Clinical Research Associate to support the execution and oversight of clinical trials and performance evaluations within a dynamic, global medical manufacturing organization. This company is an industry leader in plastic laboratory products, diagnostic technologies, and cell culture solutions, offering a highly innovative and collaborative environment.
This role is critical in ensuring the integrity, quality, and regulatory compliance of clinical studies across both internal and external research activities. It offers strong exposure to international trials, cross-functional collaboration, and opportunities for long-term growth.
Key Responsibilities
Oversee and monitor internal and external clinical performance evaluations, including development studies and post-market activities
Prepare, manage, and maintain clinical trial documentation in alignment with study protocols and internal processes
Develop and review essential study documents, including protocols and templates
Conduct site initiation visits, routine monitoring (remote and on-site), GBO lab monitoring, and close-out visits
Act as a primary liaison for investigators, key opinion leaders, consultants, CROs, and vendors
Maintain accurate and audit-ready Trial Master Files (TMF)
Train and support study teams in accordance with protocols and applicable regulatory requirements
Assist with regulatory and ethics submissions for international clinical trials
Ensure accuracy, completeness, and integrity of clinical data
Perform feasibility assessments and support site selection activities
Qualifications
Bachelor's degree in biology, medicine, pharmacy, or related field (or equivalent clinical research experience)
2-4+ years of experience as a Clinical Research Associate or Clinical Monitor within a CRO, medical device, or pharmaceutical setting
Strong working knowledge of ICH-GCP, ISO 14155, and ISO 20916
Familiarity with MDR, IVDR, and GDPR requirements
Exposure to FDA regulations, ISO standards, and CLSI guidelines is a plus
Ability to work independently in a fast-paced, evolving environment
Strong communication and stakeholder management skills
Willingness to travel as needed
Valid driver's license required
Pay Details: $63,000.00 to $100,600.00 per year
Equal Opportunity Employer/Veterans/Disabled
Military connected talent encouraged to apply
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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
The California Fair Chance Act
Los Angeles City Fair Chance Ordinance
Los Angeles County Fair Chance Ordinance for Employers
San Francisco Fair Chance Ordinance
Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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