Job Title: Research Associate – Clinical Documentation
Location: Ahmedabad, Gujarat, India
Employment Type: Full-Time
CTC Range: INR 3,00,000 – 5,00,000 per annum
Experience Required: 2–3 years
Lambda Therapeutic Research Ltd. is a global, full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India, with strategic operations in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland). Lambda offers comprehensive end-to-end clinical research services to global innovators, biotech companies, and generic pharmaceutical industries, maintaining high standards of quality, compliance, and scientific integrity.
Lambda Therapeutic Research is seeking a Research Associate with 2–3 years of experience in clinical documentation and regulatory submissions. The ideal candidate will ensure the preparation, review, and quality verification of clinical study documents, supporting clinical trials and regulatory compliance. This role requires strong analytical and scientific interpretation skills, attention to detail, and familiarity with regulatory requirements for pharmaceutical and biotech clinical research.
Prepare and review clinical study documents including:
Clinical trial protocols
Investigator brochures
Informed consent forms (ICF)
Electronic and paper case report forms (CRFs)
Clinical trial safety reports
Regulatory submission documents (e.g., CTD modules)
Perform literature searches, organize information, and critically analyze scientific data to ensure accuracy and clarity in documentation.
Conduct quality checks to ensure documents are compliant with SOPs, regulatory guidelines, and planned timelines.
Ensure deliverables meet pre-defined quality standards and deadlines.
Assist in supervising, planning, and coordinating document preparation activities across clinical projects.
Collaborate with team members to maintain consistency and accuracy in clinical documentation.
Experience: 2–3 years in clinical documentation, medical writing, or regulatory submission preparation.
Education: B.Pharm or M.Pharm.
Strong knowledge of clinical trial processes, regulatory compliance, and global documentation standards.
Excellent scientific interpretation, analytical, and critical review skills.
High attention to detail with the ability to identify and correct discrepancies.
Strong organizational and time management skills, with the ability to handle multiple projects simultaneously.
Excellent written and verbal communication skills in English.
Opportunity to work with a leading global CRO and gain exposure to international clinical trials and regulatory standards.
Collaborate with experienced clinical research professionals and multidisciplinary teams.
Hands-on experience with regulatory submissions and clinical trial documentation across multiple therapeutic areas.
Competitive compensation and benefits in a structured professional environment.
Career growth opportunities through mentorship and training programs.
Apply Today: Join Lambda Therapeutic Research to advance your career in clinical documentation and regulatory submissions while contributing to high-quality clinical research and global healthcare innovation.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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