Job DescriptionJob Description: NDepartment: Clinical Affairs NRole: Clinical Research Associate NJob Location: Corporate Office, Ahmedabad NExperience Required: 0–1 Year NQualification: M.Sc. / B.Pharm. / M.Pharm. (Life Sciences / Clinical Research / Pharmacology / Pharmaceutics) NRole Objective: Nn This role will support the coordination and execution of clinical trial activities, including regulatory and ethics committee submissions, site coordination, trial documentation, study material management and compliance with applicable SOPs, local regulations and ICH-GCP guidelines. NnDesired Candidate Profile: Nn Education: B.Pharm/M.Pharm (Pharmacology or Pharmaceutics) or M.Sc. (Life Sciences or Clinical Research) N Experience: Fresher to 1 year of relevant exposure in clinical research, clinical operations, CRO/site coordination, hospital-based clinical projects or internship/training in clinical trials. N Skills: Basic understanding of clinical trial processes, ethics committee documentation, regulatory submissions, CRFs, source documents, trial supplies and data collection requirements. N Attributes: Quick learner with attention to detail, ethical conduct, professional communication, willingness to travel for site visits when required and ability to coordinate with investigators, sites, vendors and internal teams. NnRole & Responsibilities: Nn Assist in the preparation, submission and coordination of ethics committee and regulatory dossiers for clinical trials across different study sites. N Support the registration of clinical trials on applicable platforms in accordance with local regulatory requirements. N Coordinate with study sites for the timely collection of data and study-related documents for ongoing clinical projects. N Assist in setting up clinical trial sites by ensuring the availability of required trial materials, study documents, investigational product/device and other supplies. N Collect,



track and maintain completed case report forms from study sites as per project timelines. N Support ordering, tracking, inventory management and accountability of investigational products and clinical trial materials. N Ensure clinical trial activities are conducted in compliance with approved protocols, SOPs, local regulations, ICH-GCP guidelines and applicable regulatory requirements. N Assist in clinical trial supplies management, including planning, distribution, reconciliation and documentation. N Support site-related activities, including site initiation visits, routine monitoring visits and site close-out visits. N Coordinate with internal teams, investigators, site staff, vendors and other stakeholders for smooth execution of clinical trial activities. N Identify, escalate and support resolution of study-related issues on time. N Assist in submissions related to protocol amendments, addition of trial sites and notifications to ethics committees and regulatory authorities. N Maintain accurate trialdocumentation and support Trial Master File and site file updates. N Perform other clinical operations-related tasks and responsibilities as assigned. NnFunctional Skills Required: Nn Basic knowledge of clinical trial/clinical investigation processes and study life cycle from start-up to close-out. N Understanding of ethicscommittee submissions, regulatory dossier coordination, protocol amendments, clinical trial registration and site documentation requirements. N Familiarity with ICH-GCP guidelines, SOP compliance,



informed consent process, CRFs, source documents, TMF/ISF maintenance and trial supply accountability. N Ability to maintain trackers, follow up on pending documents, review completeness of study files and coordinate with multiple stakeholders. N Positive working knowledge of MS Office tools such as Word, Excel, PowerPoint and Outlook; ability to prepare accurate documentation and reports. NnBehavioral Skills Required: Nn Strong written and verbal communication skills with professional etiquette while interacting with investigators, study coordinators, vendors and internal teams. N High attention to detail, documentation discipline and commitment to accuracy and timelines. N Ability to learn quickly, take guidance positively and work effectively under supervision. N Good planning, coordination, prioritization, and follow-up skills for handling multiple sites and project activities. N Problem-solving mindsetwith the ability to identify issues early and escalate appropriately. N Integrity, confidentiality, teamwork, adaptability and willingness to travel for site activities when required. NnThis role offers astructured learning opportunity for fresh graduates to build a career in clinical research, supporting the planning, coordination and execution of clinical trials while ensuring compliance with study protocols, regulatory requirements and organizational standards. NTeam Size to be Handled: Nn Reports to: Clinical Operations Manager. N Team Structure: Individual contributor role NnImportant Links: Nn Website: https://biotechhealthcare.Com/ N LinkedIn: https://www.Linkedin.Com/company/biotechhealthcare/ N Instagram: Biotech Vision Care NnBiotech is an equal opportunity organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.

📌 Clinical Research Associate (Sabarmati River)
🏢 Biotech Healthcare
📍 Sabarmati River