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CRA(In house)

Mumbai, MH
Job Code:
  • Biotechnology & Science
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Job Details

PURPOSEManage clinical study sites from study start-up, site initiation through to site closeout. Ensure that all clinical study objectives are met to the Sponsors satisfaction, ensuring quality deliverables on time and in accordance with SOPs, guidelines, policies and practices.RESPONSIBILITIESServe as primary point of contact and develop an understanding of how sites operate in order to build strong relationships with personnel at assigned sites.Complete appropriate therapeutic, protocol and study related trainings to perform job duties.Collaborate with other functional groups within the organization where necessary to support milestone achievement and to manage study issues and obstacles.Perform remote monitoring of clinical study data of assigned sites through use of in-house tools & software and generate report(s) for the same.Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.Evaluate the quality and timely completeness of electronic database related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Project Manager as required.Manage the assigned studies by conducting timely ethics committee submissions, follow up on patient recruitment, ensuring electronic Case Report Form (eCRF) completion and data query resolution, closure of site issues as applicable.Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and/or remote review reports, generating follow-up letters, essential document collection and filing, timely update of study trackers and other required study documentation.Establish complete adherence to the study specific plans.Coordinate with the sites for successful study supplies management.Ensure in-house & on-site audit/ inspection readiness.Prepare and maintain In-House file reconcile with Investigator Site File at defined intervals.Circulate Teleconference agenda, Minutes and Newsletters to appropriate parties. Complete archival process at the end of study, as required.REQUIRED KNOWLEDGE, SKILLS AND ABILITIESExperience of registry / non-interventional studies in indications of diabetes and/or cardiology preferred, though not limited to. or experience of working in Phase I IV studiesUnderstanding of regulated clinical trial environment and knowledge of drug development processEffective communication, organizational, planning, interpersonal, and presentation skills. Proficiency in any one regional languages (e.g. Tamil, Kannada or any other)in addition to English and Hindi is desired. Strong software and computer skills, including experience with eCRF and MS Office applicationsAbility to work independently once trained and to effectively prioritize tasksKnowledge of applicable regulatory requirements, guidelines and SOPsAbility to establish and maintain effective working relationships with coworkers, managers, sites and clients.
Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 2-4


Admin Services/Medical Facilities | Clinical Research
Applying for this job will take you to an external site


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