Clinical Research Associate (CRA)

Why This Role Matters
Clinical Research Associates play a pivotal role in the successful execution of clinical trials by ensuring that studies are conducted ethically, safely, and in compliance with regulatory standards. They act as a bridge between investigators, sponsors, patients, and regulatory authorities, ensuring that every aspect of a clinical trial meets protocol requirements. This role is essential in generating reliable clinical data that supports drug approvals and improves patient care outcomes.

Job Description
A leading multispeciality clinical research setup in Ahmedabad is hiring an Associate in the Clinical Research department. This role involves coordinating and managing day-to-day clinical trial activities while ensuring compliance with study protocols, regulatory guidelines, and institutional policies. The selected candidate will work closely with Principal Investigators (PI), sponsors, ethics committees, and patients to ensure smooth trial execution. This opportunity is ideal for professionals with 1–3 years of experience who are looking to grow in clinical research operations and site management.

Key Features of the Role: Responsibilities
• Facilitate and coordinate daily clinical trial activities at the site.
• Ensure compliance with study protocols, GCP guidelines, and regulatory requirements.
• Coordinate with sponsors, investigators, vendors, and internal departments for study execution.
• Maintain and organize Trial Master File (TMF) and regulatory documentation.
• Prepare and submit documents to Institutional Review Board (IRB) / Ethics Committee (IEC).
• Track study progress and prepare periodic reports for ongoing trials.
• Prepare trial-related documents such as visit checklists, source notes, and adverse event reports.
• Support site selection, monitoring, audit, and close-out visits.
• Assist Principal Investigator (PI) in training study staff on protocols and procedures.
• Maintain training records and study documentation.
• Extract data from source documents and enter into clinical databases accurately.
• Respond to data queries and ensure data quality and completeness.
• Maintain subject tracking logs and study databases.
• Support informed consent process and communicate study details to patients.
• Monitor patient visits and ensure proper documentation of study-related activities.
• Record adverse events (AE) and serious adverse events (SAE), and report them to Ethics Committee, Sponsor, and regulatory authorities (e.g., DCGI).
• Dispense investigational products as per protocol and maintain accountability logs.
• Collect, process, and ship biological samples (blood/urine) as per study requirements.
• Coordinate with laboratories and ensure timely review of test results by investigators.
• Manage study supplies including lab kits and investigational products.
• Participate in investigator meetings, site meetings, and study-related conferences.
• Assist in study contract finalization and agreement processes.

Eligibility Criteria

Educational Qualification
• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field

Experience
• 1 to 3 years of experience in clinical research or clinical trial coordination

Required Skills
• Strong understanding of clinical trial processes and GCP guidelines
• Knowledge of regulatory requirements (IRB/IEC, DCGI)
• Experience in clinical data entry and documentation
• Familiarity with adverse event and SAE reporting
• Proficiency in Microsoft Excel and clinical databases
• Strong organizational and time management skills
• Good communication and interpersonal abilities

Preferred Skills
• Experience in site management or hospital-based clinical trials
• Knowledge of Trial Master File (TMF) management
• Familiarity with informed consent process and patient interaction
• Experience handling monitoring and audit visits

Salary Insights
• Competitive salary as per experience (entry to mid-level clinical research role)

Benefits & Perks
• Hands-on experience in clinical trial operations
• Exposure to regulatory submissions and compliance processes
• Opportunity to work closely with investigators and sponsors
• Career growth in clinical research and site management
• Learning environment with real-world clinical trial exposure

Company Overview
This opportunity is based at a reputed multispeciality clinical research center in Ahmedabad, known for conducting ethically compliant and high-quality clinical trials. The organization collaborates with sponsors, investigators, and regulatory bodies to ensure that clinical studies are executed efficiently while maintaining patient safety and data integrity. It offers a dynamic environment for professionals to build expertise in clinical operations, regulatory affairs, and patient-centric research.

FAQs

• Is this role suitable for freshers?
No, candidates with at least 1 year of experience in clinical research are preferred.

• What is the main focus of this role?
Clinical trial coordination, patient management, and regulatory compliance.

• Does this role involve patient interaction?
Yes, it includes direct interaction with study participants and involvement in the informed consent process.

Application Tips
• Highlight your experience in clinical trials, GCP, and regulatory processes
• Mention involvement in AE/SAE reporting and data management
• Include experience with IRB/IEC submissions and TMF handling
• Emphasize communication skills and patient coordination experience