We are seeking a detail-oriented Regulatory Associate to join our Regulatory Affairs team. In this ... Collaborate with internal teams, such as clinical, quality, and product development, to ensure ...
We are seeking a detail-oriented Regulatory Associate to join our Regulatory Affairs team. In this ... Collaborate with internal teams, such as clinical, quality, and product development, to ensure ...
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Clinical Data Associate
Boston, MA ยท On-site
$50K - $62K/yr
The Data Associate is responsible for the quality control of patient data on one or more studies, working with Clinical Research Associates at member institutions, physicians and statisticians ...
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Clinical Data Associate
Boston, MA ยท On-site
$50K - $62K/yr
The Data Associate is responsible for the quality control of patient data on one or more studies, working with Clinical Research Associates at member institutions, physicians and statisticians ...
Clinical Trial Associate
Needham, MA ยท On-site
$88K - $100K/yr
The Clinical Trial Associate (CTA) role supports clinical trial execution in Ph 2 and Ph 3 trials ... Ensure the quality of data submitted from assigned study tasks and timely data submission ...
Clinical Trial Associate
Needham, MA ยท On-site
$88K - $100K/yr
The Clinical Trial Associate (CTA) role supports clinical trial execution in Ph 2 and Ph 3 trials ... Ensure the quality of data submitted from assigned study tasks and timely data submission ...
Clinical Trial Associate
Needham, MA ยท On-site
$88K - $100K/yr
The Clinical Trial Associate (CTA) role supports clinical trial execution in Ph 2 and Ph 3 trials ... Ensure the quality of data submitted from assigned study tasks and timely data submission ...
Quick apply
Clinical Trial Associate
Needham, MA ยท On-site
$88K - $100K/yr
The Clinical Trial Associate (CTA) role supports clinical trial execution in Ph 2 and Ph 3 trials ... Ensure the quality of data submitted from assigned study tasks and timely data submission ...
Senior Clinical Trial Associate
Boston, MA ยท On-site
$110K - $115K/yr
About the Role >>> Senior Clinical Trial Associate As the Senior Clinical Trial Associate reporting ... Contributes to the development of the TMF plan and conducts periodic quality control reviews and ...
Senior Clinical Trial Associate
Boston, MA ยท On-site
$110K - $115K/yr
About the Role >>> Senior Clinical Trial Associate As the Senior Clinical Trial Associate reporting ... Contributes to the development of the TMF plan and conducts periodic quality control reviews and ...
Associate Director, Quality Assurance - CMC
Boston, MA ยท On-site
$180K - $195K/yr
Seaport Therapeutics is a clinical-stage biopharmaceutical company advancing the development of ... Reporting to the Head of Quality, Seaport Therapeutics is seeking an experienced Associate Director ...
Associate Director, Quality Assurance - CMC
Boston, MA ยท On-site
$180K - $195K/yr
Seaport Therapeutics is a clinical-stage biopharmaceutical company advancing the development of ... Reporting to the Head of Quality, Seaport Therapeutics is seeking an experienced Associate Director ...
Associate Director, Quality Assurance - CMC
Boston, MA ยท On-site
$180K - $195K/yr
Seaport Therapeutics is a clinical-stage biopharmaceutical company advancing the development of ... Reporting to the Head of Quality, Seaport Therapeutics is seeking an experienced Associate Director ...
Associate Director, Quality Assurance - CMC
Boston, MA ยท On-site
$180K - $195K/yr
Seaport Therapeutics is a clinical-stage biopharmaceutical company advancing the development of ... Reporting to the Head of Quality, Seaport Therapeutics is seeking an experienced Associate Director ...
Qual Improvement Spec RN
Providence, RI ยท On-site
Monitor, analyze, and report key performance indicators (KPIs), clinical outcomes, quality measures ... An Associate Degree in Nursing (ADN) may be considered when combined with a Bachelor's or Master ...
Qual Improvement Spec RN
Providence, RI ยท On-site
Monitor, analyze, and report key performance indicators (KPIs), clinical outcomes, quality measures ... An Associate Degree in Nursing (ADN) may be considered when combined with a Bachelor's or Master ...
The Clinical Research Associate Manager maintains a working knowledge of all aspects of the ... ensure a quality-based, patient-oriented flow within the research regulatory framework. The ...
The Clinical Research Associate Manager maintains a working knowledge of all aspects of the ... ensure a quality-based, patient-oriented flow within the research regulatory framework. The ...
Licensed Behavioral Health Clin Qual Audit Analyst Sr Licensed Behavioral Health Clinical Quality ... Virtual - This role enables associates to work virtually full-time, except for required in-person ...
Licensed Behavioral Health Clin Qual Audit Analyst Sr Licensed Behavioral Health Clinical Quality ... Virtual - This role enables associates to work virtually full-time, except for required in-person ...
Clinical Trial Associate
Boston, MA ยท On-site
$36.50 - $49.75/hr
Position Summary Working closely with the Clinical Trial Manager, the Clinical Trial Associate (CTA ... Responsible for updating, maintaining and quality control of the eTMF, SharePoint site and shared ...
Clinical Trial Associate
Boston, MA ยท On-site
$36.50 - $49.75/hr
Position Summary Working closely with the Clinical Trial Manager, the Clinical Trial Associate (CTA ... Responsible for updating, maintaining and quality control of the eTMF, SharePoint site and shared ...
The incumbent will participate in quality control and quality assurance programs as they relate to clinical chemistry. In addition, the associate director of chemistry will collaboratively oversee ...
The incumbent will participate in quality control and quality assurance programs as they relate to clinical chemistry. In addition, the associate director of chemistry will collaboratively oversee ...
The incumbent will participate in quality control and quality assurance programs as they relate to clinical chemistry. In addition, the associate director of chemistry will collaboratively oversee ...
The incumbent will participate in quality control and quality assurance programs as they relate to clinical chemistry. In addition, the associate director of chemistry will collaboratively oversee ...
The incumbent will participate in quality control and quality assurance programs as they relate to clinical chemistry. In addition, the associate director of chemistry will collaboratively oversee ...
The incumbent will participate in quality control and quality assurance programs as they relate to clinical chemistry. In addition, the associate director of chemistry will collaboratively oversee ...
Associate Director, GMP Quality
Boston, MA ยท On-site
Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard ... About the Role >>> Associate Director GMP Quality As the Associate Director, GMP Quality, reporting ...
Associate Director, GMP Quality
Boston, MA ยท On-site
Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard ... About the Role >>> Associate Director GMP Quality As the Associate Director, GMP Quality, reporting ...
Associate Director, GMP Quality
$160K - $180K/yr
About the Role >>> Associate Director GMP Quality As the Associate Director, GMP Quality, reporting ... Batch disposition/ release for Clinical Trial Materials and Commercial batches * Perform technical ...
Associate Director, GMP Quality
$160K - $180K/yr
About the Role >>> Associate Director GMP Quality As the Associate Director, GMP Quality, reporting ... Batch disposition/ release for Clinical Trial Materials and Commercial batches * Perform technical ...
Vor Biopharma is seeking an Associate Director of Clinical Operations to manage our autoimmune ... Participate and respond to Quality Assurance and/or regulatory authority inspection audits
Vor Biopharma is seeking an Associate Director of Clinical Operations to manage our autoimmune ... Participate and respond to Quality Assurance and/or regulatory authority inspection audits
Vor Biopharma is seeking an Associate Director of Clinical Operations to manage our autoimmune ... Participate and respond to Quality Assurance and/or regulatory authority inspection audits
Vor Biopharma is seeking an Associate Director of Clinical Operations to manage our autoimmune ... Participate and respond to Quality Assurance and/or regulatory authority inspection audits
MRI Quality Senior Specialist
$34.38 - $50/hr
The MRI Quality Senior Specialist is an integral member of the MRI department at Boston Medical ... and clinical requirements for advanced registration in MRI as outlined by the ARRT. Associates ...
MRI Quality Senior Specialist
$34.38 - $50/hr
The MRI Quality Senior Specialist is an integral member of the MRI department at Boston Medical ... and clinical requirements for advanced registration in MRI as outlined by the ARRT. Associates ...
The Senior Associate willoperateacross multiple Epic engagements and willbe responsible forsupporting high-quality delivery across clinical implementations, optimization initiatives, stabilization ...
The Senior Associate willoperateacross multiple Epic engagements and willbe responsible forsupporting high-quality delivery across clinical implementations, optimization initiatives, stabilization ...
Clinical Quality Associate information
See Woonsocket, RI salary details
$12.21 - $15.91
3% of jobs
$15.91 - $19.62
18% of jobs
$20.35 is the 25th percentile. Wages below this are outliers.
$19.62 - $23.33
20% of jobs
The median wage is $25.58 / hr.
$23.33 - $27.03
15% of jobs
$27.03 - $30.74
11% of jobs
$30.74 - $34.45
4% of jobs
$37.60 is the 75th percentile. Wages above this are outliers.
$34.45 - $38.15
5% of jobs
$38.15 - $41.86
8% of jobs
$41.86 - $45.57
6% of jobs
$45.57 - $49.27
6% of jobs
$49.27 - $52.98
3% of jobs
$12
$30
$52
How much do clinical quality associate jobs pay per hour?
What is a clinical quality associate?
What are the key skills and qualifications needed to thrive as a clinical quality associate?
What are the main challenges clinical quality associates face when ensuring compliance across multiple clinical trial sites?
What is the difference between Clinical Quality Associate vs Clinical Research Coordinator?
| Aspect | Clinical Quality Associate | Clinical Research Coordinator |
|---|---|---|
| Required Credentials | Typically a bachelor's degree in life sciences or related field; certifications like CQA are a plus | Bachelor's degree in health sciences, biology, or related field; often requires research-specific certifications |
| Work Environment | Quality assurance departments, regulatory compliance teams, pharmaceutical or biotech companies | Clinical trial sites, hospitals, research institutions |
| Employer & Industry Usage | Used in pharmaceutical, biotech, and healthcare industries focusing on quality and compliance | Common in academic, hospital, and clinical research settings |
The Clinical Quality Associate primarily focuses on ensuring compliance with quality standards and regulatory requirements within the industry, while the Clinical Research Coordinator manages the day-to-day operations of clinical trials. Both roles require strong attention to detail and knowledge of clinical processes but differ in their core responsibilities and work environments.
Contractor
Re-posted 16 days ago
Job description
We are seeking a detail-oriented Regulatory Associate to join our Regulatory Affairs team. In this role, you will play a vital part in supporting the development and submission of regulatory documents, ensuring compliance with all regulatory standards, and facilitating the approval process for clinical trials and product launches. This position offers the opportunity to work closely with cross-functional teams and contribute to regulatory strategies across a variety of projects.
Key Responsibilities:
- Prepare, review, and submit regulatory documentation for clinical trial applications, product registrations, and approvals in compliance with relevant regulations (e.g., FDA, EMA).
- Coordinate and compile data from cross-functional teams to support regulatory submissions.
- Assist in the development of regulatory strategies to ensure timely approval and market access of products.
- Monitor and interpret regulatory guidelines and requirements to ensure compliance throughout the development lifecycle.
- Maintain up-to-date knowledge of regulatory changes and industry standards that impact submissions and processes.
- Communicate with regulatory agencies to facilitate submissions, resolve inquiries, and address any issues that may arise.
- Track the status of submissions and approvals, ensuring that deadlines are met and processes are streamlined.
- Support the creation and maintenance of regulatory documentation archives and tracking systems.
- Provide support in the preparation of regulatory meetings, presentations, and responses to agency requests.
- Collaborate with internal teams, such as clinical, quality, and product development, to ensure alignment with regulatory requirements.
Qualifications:
- Bachelor's degree in life sciences, pharmacy, health sciences, or a related field.
- 2+ years of experience in regulatory affairs, clinical research, or a related area within the pharmaceutical, biotech, or medical device industries.
- Familiarity with regulatory submission processes and understanding of regulatory requirements (e.g., FDA, EMA).
- Strong organizational and project management skills, with an emphasis on detail and accuracy.
- Excellent communication skills for interacting with regulatory bodies and cross-functional teams.
- Ability to manage multiple tasks and prioritize effectively in a fast-paced environment.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with regulatory software or databases is a plus.
Locations:
This position is open to candidates in multiple locations.
This is a contract position
About Cedent
Sourced by ZipRecruiter
CEDENT strives to attract and retain the best people and provide an environment where they can all develop professionally and build a rewarding career. As a result, we create an inclusive environment that is rich in diversity, acknowledges each individual's uniqueness and promotes respect, personal achievement and stewardship. Our clients are global and so is CEDENT. We build and maintain a global workforce that includes people from different backgrounds, with a vast range of skills and experience all united by a common culture and commitment to help our clients achieve high performance. Cultivating a diverse workforce and inclusive work environment makes business sense. Our peoples varied skills are the talent engine that powers CEDENT, enabling it in turn to deliver the innovative solutions that help our clients outperform competitors.
Industry
It services
Company size
11 - 50 Employees
Headquarters location
Plano, TX, US
Year founded
2008