Top 1906 research specialist Jobs

Clinical QA Specialist
XBiotech USA, Inc —Austin, TX
- Full-time
- Nursing
- 3 years
- Master's degree
- Health savings account
- Health insurance
Quick Apply
4d
Property Research Specialist
The Silk Companies LLC —Warwick, RI
- $17 - $21 an hour
- Full-time
- Research
- Office
- Communication skills
- Health insurance
- 401(k)
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Research & Development Specialist
Gamer's Choice —Long Island City, NY
- $65,000 - $85,000 a year
- Full-time
- Writing skills
- Mid-level
- In-person
- Health savings account
- Health insurance
2d
Property & Legal professional (title researcher and legal process)
Coleman Law —Decatur, GA
- $36,500 - $45,000 a year
- Full-time
- Background check
- Microsoft Outlook
- Travel
- Paid time off
Quick Apply
3d
Research Specialist I-II
Oklahoma State University —Stillwater, OK
- $20.25 - $27.00 an hour
- Full-time
- Mid-level
- Master's degree
- University
- Health savings account
- Health insurance
Quick Apply
7d
R&D Specialist
Crispy Cones —Rexburg, ID
- $15 an hour
- Part-time
- Google Workspace
- Writing skills
- Continuous improvement
- Employee discount
Quick Apply
11h
Research Nurse Specialist
A-Team Solutions —Bethesda, MD
- $100,000 - $135,000 a year
- Full-time
- Background check
- Nursing
- RN License
- Health insurance
- Dental insurance
Quick Apply
Health Science Specialist (Quality Assurance)
VA Boston Healthcare System —Boston, MA
- $69,905 - $90,882 a year
- Full-time
- Background check
- Mid-level
- Office
- Health savings account
- Health insurance
Quick Apply
Product Experience Specialist
Unisport Soccer —Wrentham, MA
- $23 - $27 an hour
- Full-time
- Research
- Mid-level
- In-person
- Paid training
- Health insurance
Quick Apply
Sr. Exploitation Specialist/Data Scientist (TS/SCI)
Culmen International LLC —Sneads Ferry, NC
- Full-time
- System design
- Office
- Java
- Paid holidays
- Health insurance
6d
Junior/ Entry Level Sales Support Specialist
Sympatec Inc. —Pennington, NJ
- From $70,000 a year
- Full-time
- Heavy lifting
- Engineering
- Microsoft Office
- Disability insurance
- Health insurance
Quick Apply
Physics Expert - AI trainer
micro1 —Remote
- $20 - $50 an hour
- Contract
- Remote
- Laboratory experience
- English
- Mid-level
- Flexible schedule
14d
Grant Writer & Research Specialist
Bible League International —Crete, IL
- $55,000 - $65,000 a year
- Full-time
- Hybrid work
- Background check
- Marketing
- Research
- Health savings account
- Paid holidays
Quick Apply
Pediatric Licensed Professional Counselor
Sensational Kids Pediatric Rehabilitation —Augusta, GA
- From $30 an hour
- Part-time
- Writing skills
- Licensed Clinical Social Worker
- LPC
- Health insurance
- 401(k)
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Social Media/Online Research Specialist
Open Desk —Wake Forest, NC
- $17 an hour
- Full-time
- Customer service
- Research
- Office
- Paid holidays
- Disability insurance
Quick Apply
9d
Sr. Exploitation Specialist/Data Scientist (TS/SCI)
Culmen International LLC —Fayetteville, NC
- Full-time
- System design
- Office
- Java
- Paid holidays
- Health insurance
6d
R&D Senior Specialist
Global Healthcare Group —Valhalla, NY
- $60 - $70 an hour
- Full-time
- Hybrid work
- Background check
- Bachelor of Science
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
Financial Professional
Thorpe Financial —Remote
- $75,622.16 - $86,968.82 a year
- Part-time
- Remote
- Background check
- Research
- Mid-level
- Flexible schedule
Quick Apply
Research & Development | Manufacturing Process Innovation Specialist
Dynamic Lifecycle Innovations —Onalaska, WI
- $65,000 - $105,000 a year
- Engineering
- Mid-level
- 3 years
- Profit sharing
- Paid holidays
Quick Apply
R&D Research Specialist
Jennie-O —Willmar, MN
- $21.00 - $29.25 an hour
- Full-time
- Bachelor of Science
- Mid-level
- Databases
- Profit sharing
- Employee stock purchase plan
9d

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Clinical QA Specialist

XBiotech USA, Inc -
Austin, TX

Quick Apply

Job Details

Full-time
4 days ago

Benefits

Health savings account
Health insurance
Dental insurance
401(k)
Paid time off
Parental leave
Vision insurance
Life insurance

Qualifications

Regulatory inspections
Clinical research
Clinical research audit management
Quality control audit
Vendor compliance audits
Supplier audits
Clinical audit and monitoring
Bachelor's degree
Laboratory regulatory affairs
Attention to detail
Quality improvement
Vendor communication
Organizational skills
Training & development
Quality assurance within healthcare

Full Job Description

Job description:

XBiotech USA, Inc. is currently seeking an experienced Clinical Quality Assurance (QA) Specialist to join our team in Austin, TX.

XBiotech is a fully integrated global biosciences company dedicated to pioneering the discovery, development, and commercialization of therapeutic antibodies based on its True Human™ proprietary technology.

Unlike previous generations of antibody therapies, XBiotech’s True Human™ antibodies are 100 percent human, derived from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human™ antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy, and tolerability.

Position Summary:

The Clinical QA Specialist provides strategic QA oversight across clinical development programs of XBiotech, leverages expertise to ensure clinical research operations comply with regulatory standards (ICH-GCP, FDA, EMA, etc.) and internal policies, focusing on data integrity, patient safety and process improvements.

Key Responsibilities:

Compliance and Oversight:

· Develop and maintain the Quality Management System (QMS) and SOPs, to ensure compliance with Good Clinical Practice (GCP), and Good Laboratory Practices (GLP).

· Review and approve essential clinical trial documentation (protocols, reports, SOPs, etc.) for accuracy and compliance.

· Provide QA oversight for Phase I–III clinical trials, ensuring compliance with protocols, GCP, and applicable regulations throughout the trial lifecycle.

· Evaluate and manage protocol deviations and serious breaches in accordance with regulatory requirements.

· Collaborate with Clinical Operations, Data Management, Pharmacovigilance, and Regulatory Affairs to embed quality throughout clinical development.

CAPA and Risk Management:

· Manage the development, implementation and effectiveness of Corrective and Preventive Actions (CAPA).

· Perform root cause analysis for compliance issues. Conduct risk assessments and implement mitigation strategies.

· Track issues to resolution and trend data for systemic improvements.

· Proactively identify, report and mitigate risks within clinical research processes.

Audit and Inspection Readiness:

· Plan and execute QA audits of clinical trial sites, vendors, CROs, and internal processes.

· Conduct vendor qualification audits and ongoing oversight of third-party providers.

· Review and trend Audit Reports to propose process improvements.

· Prepare for and host regulatory inspections, ensuring all documentation is ready. Review audit findings and ensure timely resolution.

Training:

· Provide training on GCP and quality standards to staff and foster a culture of quality.

QUALIFICATIONS/EXPERIENCE REQUIRED:

· Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field. Master’s degree preferred.

· 5-7+ years of clinical research experience, including QA experience (3+ years) is required.

· Experience with regulatory inspections (FDA/EMA) preferred.

· Demonstrated experience planning and conducting clinical site and vendor audits, and hosting regulatory audits.

· Demonstrated competencies in GCP and regulatory compliance knowledge

· Proficiency with Electronic Data Capture (EDC) and eTMF systems.

· Excellent written and verbal communication skills.

· Must be a self-motivated and detail-oriented person who works well in a team setting.

· Must be willing to learn and adapt to changes in a fast-paced working environment.

·Must be able to multitask and have strong organizational skills.

Benefits:

401(k)
Dental insurance
Health insurance
Health savings account
Life insurance
Paid time off
Parental leave
Vision insurance

Education:

Bachelor's (Required)

Experience:

Clinical research: 5 years (Required)
QA: 3 years (Required)

Work Location: In person

Quick Apply

Refine Your Search

research specialist jobs

Clinical QA Specialist

Property Research Specialist

Research & Development Specialist

Property & Legal professional (title researcher and legal process)

Research Specialist I-II

R&D Specialist

Research Nurse Specialist

Health Science Specialist (Quality Assurance)

Product Experience Specialist

Sr. Exploitation Specialist/Data Scientist (TS/SCI)

Junior/ Entry Level Sales Support Specialist

Physics Expert - AI trainer

Grant Writer & Research Specialist

Pediatric Licensed Professional Counselor

Social Media/Online Research Specialist

Sr. Exploitation Specialist/Data Scientist (TS/SCI)

R&D Senior Specialist

Financial Professional

Research & Development | Manufacturing Process Innovation Specialist

R&D Research Specialist

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