Clinical Research Coordinator - Freshers Only

Clinical Research Coordinator (Freshers)\n\nLocation: Remote\nOrganization: Clinogenesis Research Organization\nDepartment: Clinical Operations\nEmployment Type: Full-Time\n\nRole Overview:\nThe Clinical Research Associate (CRA) is the primary link between the sponsor and the clinical study sites. This role is responsible for monitoring clinical trials to ensure the safety of participants and the integrity of data. You will be tasked with ensuring site performance, protocol adherence, and regulatory compliance throughout the lifecycle of clinical studies.\n\nKey Responsibilities:\n\nSite Monitoring: Conduct Pre-study, Initiation, Routine Monitoring, and Close-out visits to ensure protocol compliance.\nData Verification: Perform Source Data Verification (SDV) to ensure trial data is accurate, complete, and verifiable.\nSite Management: Provide guidance to study coordinators and investigators on study procedures and GCP requirements.\nRegulatory Oversight: Ensure that all Essential Documents are maintained in the Investigator Site File (ISF) and are audit-ready.\nAdverse Event Reporting: Ensure all Serious Adverse Events (SAEs) are reported within the mandated timelines.\nSubject Safety: Monitor patient recruitment and retention to ensure study milestones are met without compromising safety.\nInvestigational Product (IP): Oversee the accountability, storage, and dispensing of investigational products at the site.\n\nEducation Qualification:\n\nB.Pharm / M.Pharm or Pharm.D.\nB.Sc / M.Sc in Life Sciences (Biotechnology, Microbiology, Biochemistry).\nBDS / BHMS / BAMS / MBBS.\nAdvanced Certification in Clinical Research/Clinical Data Management is highly preferred.\n\nRequired Skills:\n\nSolid understanding of ICH-GCP, local regulatory requirements (CDSCO), and clinical trial protocols.\nAbility to travel frequently to various clinical trial sites.\nStrong critical thinking and problem-solving skills for site-related issues.\nExcellent interpersonal and communication skills to build professional relationships with investigators.\nProficiency in Clinical Trial Management Systems (CTMS) and EDC software.\nHigh level of ethics and professional integrity.\n\n#clinicalresearchjobs #clinicalresearchassociate #CRA #clinicaltrials #hiring2026 #pharmajobs #lifesciencegraduates #clinicalresearch #clinicaloperations #hiring #jobopening #career #pharmacy #biotech #clinicalresearchcareer #clinogenesisresearchinstitute #fieldjobs #drugdevelopment #GCP #regulatorycompliance