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| Job Location | Pune |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | Production |
| EmploymentType | Full-time |
One of our client which is into Clinical Research is looking for :Clinical Research AssociateLocation : PuneJob Responsibilities:Expert knowledge of ICH-GCP, Schedule Y, New drugs and the cosmetic rule and applicableregulatory requirements and ability to train others on guidelines applicable for ClinicalOperations.Conduction of qualification, initiation, monitoring, and closeout visits for research sites incompliance with the approved protocol.Communication with the medical site staff including coordinators, clinical research physiciansand their site staff.Verifying adequate Investigator qualifications, training and resources, including facilities,laboratories, equipment, and staff.Medical record and research source documentation verification against case report form data,including informing the site staff of any entry errors, ensuring good documentation practicesare being adhered to and communicating protocol deviations appropriately per SOPs, GCPand applicable regulatory requirements.Verification that the Investigator is enrolling only eligible subjects as per study requirements.Ability to assess completeness/accuracy and maintenance of regulatory documents in-house(CSF) /on-site (ISF).Ensure that the IMP is stored under appropriate protocol specified conditions andaccountability is maintained in-house and at the site.Verification and review of adverse events, serious adverse events, concomitant medicationsand corresponding illnesses to confirm accurate data reporting in accordance with theprotocol and applicable regulatory requirements.Identify issues in the project proactively and propose resolution and demonstrate ability toassess and problem solve with assistance and escalates issues when appropriate.Assessing the clinical research sites patient recruitment and retention success and offeringsuggestions for improvement.Completion of monitoring reports and follow-up letters, which includes providing summariesof the significant findings, deviations, deficiencies, and recommended actions to securecompliance within timelines.Contact to clients Telephonic contact as well as email to clientsAble to resolve any CRO related queries of clientsMaintain the good relation with the client for CROTake a time to time follow-ups with clientsDatabase collection &maintenanceCommunication with vendorsAchieving targetRequired Education:Life Science Graduate UG/ PG / Masters in Clinical Research.Required Experience:2-5 years as a clinical research associateOther Requirements:40%-60% of travel required.Proficiency in handling technical assets like laptop, MS office, Outlook, IWRS, RMP, eCRF etc.Salary : Negotiable.Interested candidates can apply to us.
Keyskills :
clinical researchgcpclinical trials