Are you looking to take the next step in your clinical research career? Do you have hands-on experience in BA/BE studies and a strong understanding of regulatory guidelines? If yes, this opportunity could be the perfect match for you!
Synergen Bio is currently hiring Clinical Research Associates (CRA) to strengthen its growing clinical research team in Pune. This role offers excellent exposure to bioequivalence studies, regulatory compliance, and cross-functional collaboration in a professional research environment.
🧬 About the Role: Clinical Research Associate (CRA)
The Clinical Research Associate (CRA) position is a critical role in ensuring the smooth execution of BA/BE clinical studies while maintaining the highest standards of data integrity, compliance, and quality. As a CRA, you will work closely with investigators, bioanalytical teams, statisticians, and internal stakeholders to ensure that studies are conducted according to SOPs and applicable regulatory guidelines.
This role is ideal for professionals who are detail-oriented, proactive, and passionate about clinical research operations.
📌 Position Details
Job Title: Clinical Research Associate (CRA)
Number of Vacancies: 02
Job Location: Shivajinagar, Wakadewadi, Pune
Experience Required: 01 to 02+ years
Qualification: M.Sc / B.Pharm
Joining Preference: Immediate joiners preferred
🧑🔬 Key Roles & Responsibilities
As a Clinical Research Associate, your responsibilities will include, but are not limited to, the following:
📋 Study Execution & Documentation
Execute assigned BA/BE studies strictly as per approved SOPs and applicable regulatory guidelines
Prepare, compile, and maintain Essential Documents in the Trial Master File (TMF)
Ensure proper accountability, review, and maintenance of study-related documents
📊 Data Review & Compliance
Review CRFs and raw data for accuracy, completeness, and consistency
Ensure study documentation meets quality standards and regulatory expectations
Provide timely compliance with QC and QA observations
🔄 Cross-Functional Coordination
Prepare and share clinical updates with bioanalytical and statistics teams
Maintain effective communication between study teams and internal departments
📝 Informed Consent & Study Activities
Perform informed consent presentation and obtain consent during screening and study phases
Carry out registration and screening-related activities as per protocol
📚 SOP & Training
Assist in the preparation and review of SOPs
Provide training to staff as required to ensure adherence to procedures
💊 Pharmacy & Additional Responsibilities
Perform pharmacy-related activities when required
Carry out any other tasks delegated by the Head CR, Principal Investigator (PI), or Manager – Operations
🌟 Why Join Synergen Bio?
Working at Synergen Bio provides a valuable opportunity to grow within the clinical research industry. You will gain exposure to real-world BA/BE studies, regulatory practices, and quality systems while working with experienced professionals.
This role offers:
Hands-on experience in regulated clinical trials
Professional learning and skill development
A collaborative and research-driven work environment
Career growth opportunities in clinical research operations
🎯 Who Should Apply?
This position is best suited for:
Clinical research professionals with 1–2+ years of experience
Candidates with strong documentation and coordination skills
Individuals who understand ICH-GCP, SOPs, and regulatory guidelines
Immediate joiners who are eager to contribute to ongoing studies
📩 How to Apply?
Interested candidates are requested to share their updated CV at:
📌 Mention the position name “Clinical Research Associate (CRA)” in the subject line for faster processing.
🔍 Final Thoughts
If you are passionate about clinical research and want to work in a structured, quality-driven environment, this Clinical Research Associate job in Pune is an excellent opportunity to advance your career. With exposure to BA/BE studies, regulatory documentation, and cross-functional collaboration, this role can significantly enhance your professional journey.
Don’t miss this chance—apply today and take the next step in your clinical research career! 🚀🧪
