Syneos Health has announced a new career opportunity for the position of Clinical Research Associate II (CRA II) for its Mumbai, Maharashtra location. This is a full-time hybrid role designed for experienced clinical research professionals with strong expertise in onsite clinical monitoring and Oncology clinical trials.
The company is looking for candidates with at least 3 years of onsite monitoring experience, sound knowledge of ICH-GCP guidelines, and the ability to manage multiple clinical trial sites while ensuring regulatory compliance and data quality.
Syneos Health Recruitment 2026 – Overview
| Particulars | Details |
|---|---|
| Company Name | Syneos Health |
| Job Role | Clinical Research Associate II (CRA II) |
| Department | Clinical Development |
| Job Location | Mumbai, Maharashtra |
| Work Mode | Hybrid |
| Employment Type | Full-Time |
| Qualification | Bachelor’s Degree, RN, or Equivalent Qualification |
| Experience | Minimum 3 Years of Onsite Monitoring Experience |
| Therapeutic Area | Oncology |
| Application Mode | Online |
Job Responsibilities
The selected candidate will be responsible for:
- Conduct site qualification, site initiation, interim monitoring, and close-out visits.
- Perform onsite and remote monitoring activities in compliance with study protocols and regulatory requirements.
- Ensure compliance with ICH-GCP, Good Pharmacoepidemiology Practices (GPP), company SOPs, and applicable regulations.
- Verify informed consent procedures and maintain patient confidentiality.
- Monitor patient safety, protocol deviations, pharmacovigilance issues, and clinical data integrity.
- Perform Source Data Verification (SDV) and Source Document Review (SDR).
- Verify Case Report Forms (CRFs) for accuracy and completeness.
- Resolve data queries and coordinate with study sites to ensure timely data cleaning.
- Monitor Electronic Data Capture (EDC) compliance.
- Manage Investigational Product (IP) accountability, reconciliation, storage, and dispensing activities.
- Review and reconcile Investigator Site Files (ISF) with Trial Master Files (TMF).
- Prepare monitoring reports, follow-up letters, communication logs, and essential study documentation.
- Support patient recruitment, retention, and study awareness initiatives.
- Coordinate with investigators, study coordinators, sponsors, and project teams.
- Participate in Investigator Meetings, sponsor meetings, and project training sessions.
- Support audit readiness and regulatory inspections.
- Assist in mentoring junior Clinical Research Associates when required.
Educational Qualification
Candidates should possess one of the following qualifications:
- Bachelor’s Degree in Life Sciences
- Bachelor’s Degree in Pharmacy (B.Pharm)
- Pharm.D
- Nursing (RN)
- Medicine
- Biotechnology
- Other related healthcare or scientific disciplines
Equivalent education and relevant clinical research experience may also be considered.
Experience Required
Applicants should have:
- Minimum 3 years of onsite clinical monitoring experience
- Mandatory experience in Oncology clinical trials
- Experience in Clinical Research Organizations (CROs) or pharmaceutical companies will be preferred.
Required Skills
The ideal candidate should have expertise in:
- Clinical Trial Monitoring
- Oncology Clinical Trials
- Site Qualification Visits (SQV)
- Site Initiation Visits (SIV)
- Interim Monitoring Visits (IMV)
- Close-Out Visits (COV)
- ICH-GCP Guidelines
- Good Pharmacoepidemiology Practices (GPP)
- Clinical Trial Management
- Source Data Verification (SDV)
- Source Document Review (SDR)
- Electronic Data Capture (EDC)
- Case Report Forms (CRFs)
- Trial Master File (TMF)
- Investigator Site File (ISF)
- Investigational Product (IP) Management
- Pharmacovigilance
- Regulatory Compliance
- Audit Readiness
- Clinical Documentation
- Communication and Stakeholder Management
Travel Requirement
Candidates should be willing to travel up to 75% as required for clinical monitoring activities.
Salary Details
Syneos Health has not officially disclosed the salary for this position.
Based on industry standards, professionals with 3+ years of CRA experience and Oncology monitoring expertise may expect an estimated annual salary ranging from ₹10 LPA to ₹18 LPA, depending on qualifications, therapeutic area expertise, monitoring experience, and interview performance.
Employees may also receive:
- Hybrid work flexibility
- Performance-based incentives
- Health and insurance benefits
- Learning and development programs
- Global clinical trial exposure
- Career growth opportunities
- Employee benefits as per company policy
Job Location
Mumbai, Maharashtra, India
Work Mode: Hybrid
How to Apply
Interested and eligible candidates can apply online through Syneos Health’s official careers portal.
Before submitting the application, candidates should ensure that their resume highlights:
- Oncology clinical trial experience
- Onsite monitoring expertise
- ICH-GCP knowledge
- Site management experience
- EDC, CRF, TMF, and ISF experience
- Regulatory compliance and audit readiness
Why Join Syneos Health?
Syneos Health is a leading global Clinical Research Organization (CRO) supporting pharmaceutical, biotechnology, and medical device companies in accelerating clinical development. Working as a CRA II provides opportunities to manage global clinical studies, collaborate with international sponsors, strengthen oncology expertise, and advance your career in clinical operations.
Frequently Asked Questions (FAQs)
What is the job role offered by Syneos Health?
Syneos Health is hiring for the position of Clinical Research Associate II (CRA II).
What experience is required?
Candidates should have at least 3 years of onsite clinical monitoring experience, along with mandatory Oncology therapeutic area experience.
What is the job location?
The position is based in Mumbai, Maharashtra, with a hybrid work model.
Is travel required for this role?
Yes. Candidates should be willing to travel up to 75% for site monitoring activities.
What qualifications are required?
Candidates should have a Bachelor’s Degree, Nursing qualification (RN), Pharmacy, Life Sciences, or another related healthcare discipline, along with relevant clinical research experience.
