Vopec Pharmaceuticals Private Limited, an innovative research-driven biopharmaceutical company, has announced exciting opportunities for Clinical Research Associates (CRAs) to support its ongoing Phase II oncology clinical trials across India.
The company is currently advancing its proprietary anti-cancer investigational drug AB001, a next-generation small-molecule immunotherapy targeting PD-L1 and multiple cancer pathways. The molecule has already received US FDA Orphan Drug Designations for pancreatic cancer, glioblastoma multiforme, and acute myeloid leukemia.
This recruitment offers pharmacy and life sciences professionals an opportunity to contribute to a potentially groundbreaking oncology therapy while gaining exposure to large-scale multicentric clinical trials across India.
Job Details
- Position: Clinical Research Associate (CRA)
- Openings: 2
- Employment Type: Full-Time, Permanent
- Department: Research & Development
- Industry: Pharmaceutical & Life Sciences
- Clinical Trial Phase: Phase II
- Therapeutic Area: Oncology
- Clinical Sites: 45 Premium Sites Across India
- Study Participants: 240 Patients
- Trial Indications: Oral Cancer, Lung Cancer, Pancreatic Cancer
About AB001 Investigational Drug
AB001 is Vopec Pharmaceuticals’ proprietary anti-cancer investigational new drug designed to target multiple cancer pathways, including PD-L1. Following encouraging Phase I safety and efficacy data, the company is progressing into Phase II trials across multiple oncology indications.
The program represents a rare opportunity to work on a globally significant, first-in-class therapeutic candidate with potential applications in difficult-to-treat cancers.
Key Responsibilities
Site Monitoring
- Conduct Site Qualification Visits (SQV)
- Perform Site Initiation Visits (SIV)
- Conduct routine monitoring visits
- Execute site close-out activities across assigned clinical trial locations
Protocol and Regulatory Compliance
- Ensure adherence to study protocols
- Maintain compliance with ICH-GCP guidelines
- Follow CDSCO regulations and NDCT Rules
- Ensure implementation of local SOPs
Source Data Verification
- Perform Source Data Verification (SDV)
- Review source documentation
- Verify accuracy and completeness of CRFs and eCRFs
- Ensure data integrity and audit readiness
Investigator and Site Management
- Build relationships with Principal Investigators
- Coordinate with study coordinators
- Support patient recruitment activities
- Resolve site-related operational issues
Investigational Product Management
- Monitor investigational product accountability
- Verify storage conditions
- Ensure proper dispensing documentation
- Maintain drug accountability records
Documentation and Quality Management
- Maintain Trial Master Files (TMF)
- Ensure Investigator Site Files (ISF) are complete
- Prepare documentation for audits and inspections
- Maintain regulatory documentation accuracy
Eligibility Criteria
Educational Qualifications
Candidates with the following qualifications are eligible:
- B.Pharm
- M.Pharm
- Pharm.D
- Bachelor’s Degree in Life Sciences
- Master’s Degree in Life Sciences
- Related Clinical Science Degrees
- D.Pharm Diploma holders with relevant experience
Experience Requirements
- Minimum 1 year of experience as a Clinical Research Associate
- Experience in clinical trial monitoring or management
- Experience in CROs, pharmaceutical companies, or major clinical trial sites
- Senior clinical coordinators with monitoring exposure may also be considered
Preferred Qualifications
- Prior oncology clinical trial experience
- Knowledge of cancer therapeutics and oncology protocols
- Hands-on experience with Electronic Data Capture (EDC) systems
- Experience using electronic Trial Master Files (eTMF)
Required Skills
Successful candidates should possess:
- Strong understanding of ICH-GCP guidelines
- Knowledge of CDSCO regulations and NDCT Rules
- Excellent communication skills
- Problem-solving and analytical abilities
- Relationship management skills
- Documentation and reporting expertise
- Ability to manage multiple trial sites
- Willingness to travel extensively across India
Why Join Vopec Pharmaceuticals?
Work on a Global Oncology Program
Contribute directly to the development of AB001, an innovative anti-cancer investigational drug with orphan drug designations in multiple indications.
Extensive Clinical Trial Exposure
Gain experience managing a network of 45 premium clinical research sites and multicentric Phase II oncology studies.
Career Growth
Collaborate with leadership teams in a dynamic, research-focused environment where your contributions directly influence clinical development and patient outcomes.
How to Apply
