Top 11 Senior clinical research coordinator Jobs in Apex Nc

Sr Clinical Research Associate
Veranex, Inc. —Raleigh, NC
- $98,400 - $140,690 a year
- Full-time
- Remote
- Microsoft Excel
- Microsoft Outlook
- 5 years
Quick Apply
FSP Sr. Clinical Research Associate II - NYC Metro or PHL - Onc
Fortrea —Durham, NC
- $125,000 - $140,000 a year
- Full-time
- Up to 50% travel
- 5 years
- Office
Senior Clinical Research Associate (level dependent on experience)
CTI Clinical Trial Services, Inc —Raleigh, NC
- Hybrid work
- Nursing
- Mid-level
- Master's degree
- Paid parental leave
- Tuition reimbursement
Quick Apply
Senior Clinical Research Coordinator
Velocity Clinical Research, Inc. —Raleigh, NC
- Part-time
- English
- Ability to sit for extended periods
- Organizational skills
- Paid holidays
- Health insurance
Quick Apply
Senior Clinical Research Associate
Parexel —Raleigh, NC
- Email
- Remote
- Master's degree
- Bachelor's degree
- Travel
- Referral program
9d
Senior Clinical Research Associate - US
Optimapharm d.o.o. —Durham, NC
- $100,000 - $130,000 a year
- Full-time
- Remote
- Nursing
- 5 years
- Computer literacy
- Health insurance
- Dental insurance
Senior Clinical Research Associate
Pedestal Health —Research Triangle Park, NC
- Hybrid work
- 5 years
- Office
- Bachelor's degree
- Paid parental leave
- Health insurance
11h
Business Analytics Senior Advisor - Clinical & Health Outcomes Research (Medical/Scientific Writing) - Hybrid
The Cigna Group —Raleigh, NC
- $112,800 - $188,000 a year
- Online Application
- 5 years
- Master's degree
- SQL
- Paid holidays
- Health insurance
Senior Clinical Research Associate, Early Clinical Development
IQVIA —Durham, NC
- $87,200 - $169,300 a year
- Full-time
- Mid-level
- Bachelor's degree
- Travel
Senior Clinical Research Associate - CNS/Rare Disease - Midwest - Remote
Worldwide Clinical Trials —Research Triangle Park, NC
- Full-time
- Remote
- Nursing
- 5 years
- English

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Senior Clinical Research Associate (level dependent on experience)
CTI Clinical Trial Services, Inc —Raleigh, NC
Creates and implements subject enrollment strategies for assigned investigative sites. Additionally, all CRAs are able keep their hotel points and airline miles…
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Senior Clinical Research Associate
Parexel —Raleigh, NC
Education requirements: Bachelor’s degree or equivalent in biological science, pharmaceutical sciences, chemistry, biotechnology, biomedical engineering, or a…
9d

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Senior Clinical Research Coordinator
OhioHealth —Columbus, OH
Implements the requirements of clinical research protocols in compliance with local, state, institutional, Federal (FDA, DHHS) and sponsor requirements.
9d
Senior Research Regulatory Coordinator - RI Gene Ther
Nationwide Children's Hospital —Columbus, OH
Bachelor’s degree or equivalent experience in medical/science field. Reviews study protocols in order to write consent/assent documents and develop the initial…
12d

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Sr Clinical Research Associate

Veranex, Inc. -
Raleigh, NC

Quick Apply

Job Details

Full-time
$98,400 - $140,690 a year

Qualifications

Research project management
Microsoft Excel
Microsoft Outlook
Biomedical regulatory compliance
Managing projects
Clinical quality assurance standards
Cross-functional collaboration
Medical terminology
Cross-functional communication
FDA regulations

Full Job Description

Veranex’s mission as an Innovation CRO is to improve patient outcomes by accelerating our clients’ innovations to market. As the world’s only end-to-end professional services firm focused on MedTech, we take clients’ Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting.

The Veranex Clinical Operations team is a dynamic group of professionals providing regulatory, quality and clinical services for the medical device industry. Our team supports start-ups, mid-sized private companies, and the largest corporations at all stages of the product life cycle. We work across a broad spectrum of technologies and treatment modalities. Our clients develop both next-generation and paradigm-shifting devices. Our product exposure includes implantables, instruments (manual, laser, robotic, etc.), capital equipment, combination products, software as a medical device (SaMD), medical mobile apps, in vitro diagnostics and more

About This Role:
Veranex has an exciting opportunity to join our team as a Senior Clinical Research Associate to support our Clinical Operations team. The Sr. CRA will participate in the planning, development, and execution of clinical trials to evaluate the safety, effectiveness and performance of medical devices. Under management supervision, the Sr. CRA will monitor assigned clinical trials to ensure adherence to the clinical protocol, applicable regulations, and company Standard Operating Procedures (SOPs) governing clinical studies.
Location: Remote, US

What You Will Do:

Responsible for ensuring that study investigators and coordinators comply with the study protocol, Good Clinical Practices (GCPs), Code of Federal Regulations (CFRs), and Institutional Review Board (IRB)/Ethics Committee (EC) requirements during clinical studies by training/guidance of investigators/research coordinators, conducting periodic on-site evaluations and follow-up of corrective actions
Acts as primary liaison to clinical sites.
Conducts site qualification visits, study start-up activities (essential document collection), site qualification visits, site initiation visits and training, monitoring visits for source data verification (reported study data are accurate, complete, and verifiable from source documents in the site’s medical records), and site close-out visits. Generates high-quality site qualification, initiation, monitoring, and close-out visit reports in timely manner (in accordance with the Clinical Monitoring Plan)
Contributes to protocol, informed consent, case report form (CRF) and study plan development as well as annual progress reports (APRs) and the clinical study report (CSR) at study conclusion to report the study results to FDA and other regulatory authorities
Ensures that the rights and well-being of human subjects are protected and confirms data quality/integrity by maintaining site compliance, reviewing adverse events and device deficiencies, reviewing data trending/metrics, reviewing audit reports, and implementing corrective actions as necessary
Supports maintenance of department SOPs and work instructions
Supports investigational device traceability including documentation for forecasting, shipping, receipt, and disposition.
Supports and maintains documentation of all clinical research activities in the study trial master file (TMF), e.g., monitoring reports, site correspondence, device inventory information.
Drives trial enrollment and identifies and communications potential and actual obstacles to enrollment.
Travel requirement: 25-50%

Qualifications:Required skills:

Minimum of 5 years of directly related work experience or equivalent in clinical research, including work on medical device significant risk IDE trials and/or non-significant risk abbreviated IDE trials.
Must be able to work autonomously and as a member of a cross-functional team and meet high expectations and tight deadlines. May work on highly visible projects in high-pressure situations
Must have working knowledge of Good Clinical Practices (GCPs), FDA regulations and IRB requirements.
Must have strong project management competencies and ability to work with high quality, reliability, and attention to detail.
Must have a strong level of professionalism, including verbal and written communication skills; and the ability to communicate with all levels of the organization, cross-functionally, and with clients/partners.
Must have proficiency in using Microsoft Office Suite, including Word, Excel, Outlook and PowerPoint; as well as experience with electronic data capture (EDC) and electronic Trial Master File (eTMF) systems.
Experience interfacing successfully with physicians/clinical staff and familiarity with hospital/clinical environments
Familiarity with medical and anatomical terminology.
Ability and willingness to travel

Preferred:

BS or BA degree preferred; BS or BA in a relevant scientific discipline or related field also preferred.

Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.

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senior clinical research coordinator jobs in apex nc

Sr Clinical Research Associate

FSP Sr. Clinical Research Associate II - NYC Metro or PHL - Onc

Senior Clinical Research Associate (level dependent on experience)

Senior Clinical Research Coordinator

Senior Clinical Research Associate

Senior Clinical Research Associate - US

Senior Clinical Research Associate

Business Analytics Senior Advisor - Clinical & Health Outcomes Research (Medical/Scientific Writing) - Hybrid

Senior Clinical Research Associate, Early Clinical Development

Senior Clinical Research Associate - CNS/Rare Disease - Midwest - Remote

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