Amaris Hiring QA/RA Senior Research Associate – Clinical Research
- Company Overview
- Job Role & Responsibilities
- Key Responsibilities:
- Eligibility / Qualifications
- Educational Qualification:
- Experience:
- Required Skills:
- Location & Salary
- Job Location:
- Salary:
- Application Process
- How to Apply:
- Why Join Amaris Clinical
- Frequently Asked Questions (FAQs)
- 1. What role is available at Amaris Clinical?
- 2. How many vacancies are available?
- 3. What qualifications are required?
- 4. What experience is needed?
- 5. How can I apply?
- Summary
Amaris Clinical, a division of Caplin Point Laboratories, is hiring for 2 vacancies in the Quality Assurance – Regulatory Affairs (QA/RA) department for the role of Senior Research Associate. This opportunity is ideal for candidates with 2 to 5 years of experience in clinical research, especially those with strong exposure to GCP compliance, Trial Master File (TMF) review, and regulatory documentation. The position is suited for B.Pharm and M.Pharm graduates looking to advance their careers in clinical operations and regulatory affairs within a growing pharmaceutical and clinical research organization.
Company Overview
Amaris Clinical operates under Caplin Point Laboratories, a well-established pharmaceutical company known for its strong presence in regulated and semi-regulated markets. The organization focuses on clinical research, regulatory compliance, and delivering high-quality healthcare solutions.
With a commitment to innovation and compliance, Amaris Clinical plays a key role in ensuring that clinical trials meet global standards such as GCP, GLP, and regulatory authority guidelines. The company provides professionals with exposure to real-world clinical research environments, regulatory documentation processes, and trial management systems.
Working here offers the chance to contribute directly to drug development and clinical research processes that impact patient safety and therapeutic outcomes worldwide.
Job Role & Responsibilities
The QA/RA Senior Research Associate will be responsible for ensuring compliance and quality across clinical trial documentation and processes.
Key Responsibilities:
- Review clinical study protocols and ensure regulatory compliance
- Perform Trial Master File (TMF) review and maintain TMF index accuracy
- Handle regulatory documentation, submissions, and tracking activities
- Oversee in-process clinical activities such as screening, dosing, and sample handling
- Manage investigational product (IP) handling and documentation
- Ensure compliance with GCP, GLP, and regulatory guidelines
- Review SOPs, equipment qualification, calibration, and maintenance records
- Coordinate with cross-functional clinical teams for documentation and compliance
Eligibility / Qualifications
Educational Qualification:
B.Pharm, M.Pharm (Pharmacy, Clinical Research, Life Sciences)
Experience:
- 2 to 5 years of experience in clinical research or regulatory affairs
Required Skills:
- Strong knowledge of GCP and GLP regulatory requirements
- Experience in Trial Master File (TMF) management and protocol review
- Understanding of clinical trial processes and documentation
- Ability to manage multiple tasks and timelines efficiently
- Strong organizational and documentation review skills
Location & Salary
Job Location:
Location details are associated with Amaris Clinical operations (candidates can confirm during application process)
Salary:
Salary will be offered based on experience and industry standards, along with growth opportunities in clinical research and regulatory affairs.
Application Process
Interested candidates can apply by sharing their updated resume via email.
How to Apply:
- Email your CV to: hr@amarisclinical.com
Ensure your resume highlights your experience in clinical trials, regulatory documentation, and QA processes to improve selection chances.
Why Join Amaris Clinical
Amaris Clinical offers a focused career path in clinical research and regulatory affairs, providing professionals with hands-on exposure to trial documentation, compliance systems, and regulatory submissions.
Key benefits include:
- Work with a reputed pharmaceutical group (Caplin Point)
- Exposure to global clinical trial standards
- Opportunity to build expertise in regulatory affairs and QA systems
- Career growth in clinical operations and research domains
Frequently Asked Questions (FAQs)
1. What role is available at Amaris Clinical?
QA/RA Senior Research Associate role in clinical research.
2. How many vacancies are available?
There are 2 open positions.
3. What qualifications are required?
B.Pharm or M.Pharm graduates are eligible.
4. What experience is needed?
Candidates must have 2 to 5 years of clinical research or regulatory experience.
5. How can I apply?
You can apply by sending your CV to hr@amarisclinical.com.
Summary
| Company | Amaris Clinical (Caplin Point Laboratories) |
|---|---|
| Vacancies | QA/RA Senior Research Associate |
| Required Education | B.Pharm, M.Pharm |
| Experience | 2 to 5 Years |
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