Clinical Research Associate, Mumbai (Male candidate with PG in CR)

Job Description

Clinical Research Associate Regrow Biosciences is a sponsor company doing various stem cell and cell based therapy products clinical trials for life threatening diseases. This role will be an opportunity to learn and provide growth arena. Here the resource will be involved in handling regulatory meetings and communications. Desired Candidate ProfileGood communication Skills in Hindi and English.Should have done Post Graduation / Diploma in Clinical ResearchShould be comfortable travelling Additional Responsibilities:

• License Approval, Audit handling, Product presentation for doctors.
• Regulatory and Ethics committee meetings
• Funding Activities from the government agencies for clinical trials.

Clinical Trials:1. Selection of the Investigators based on the therapeutic area as per the available database.2. Selection of the study sites and its assessment to ensure the study site, facility and staff are appropriate for the conduct of the study.3. Contracts/ agreements with the vendors and investigators along with the budgeting4. Plan/ conduct study start-up meeting with the team members5. Plan/ conduct of the investigator meeting6. Monitoring of the study progress to ensure study is conducted as per the protocol and other applicable regulatory requirements.7. Monitor and track patient enrollment and study progress8. Perform site audits with CRO for source data and another related documents review.9. Follow-up with the sites for patient follow-up visit10. Assist the CRO in problem solving on monitoring and study related activities.11. Assurance for timely completion of study and within stipulated budgets12. Training to the CRA and project members13. Monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned investigative/physician sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP, and/or all applicable local and federal regulatory requirements.14. Site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and protocol compliance.15. Evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.16. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.17. Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.18. Assesses factors that might affect subject/patients safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations issues.19. Conduct Source Document Review of appropriate site source documents and medical records20. Verification of required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records21. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines22. Verify site compliance with electronic data capture requirements23. Perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. 24. Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.25. Understands project scope, budgets, and timelines for own and others activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. 26. Effective CRO management that includes review and selection of CROs for clinical studies. Provide comprehensive & effective training to CROs, site personnel, Investigators etc., to enhance clinical study effectiveness.27. Perform clinical data review of data listings and summary tables, including query generation.28. Responsible for review or approval of IP release packages.29. Write or contribute to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents.30. Organize and make presentations at Investigator Meetings31. Report, write narratives and follow-up on serious adverse experiences32. Perform other duties as assigned by managementRegulatory Affairs:1. Handling State, Zonal & Central licensing authorities of India and abroad.2. Submission of various forms to obtain approval for clinical trial or manufacture & market of products.3. Preparation of technical dossiers and submission to Regulatory Authority.4. Attending meetings and query resolution received from Regulatory Authority.5. Preparation and attending Regulatory audits for GMP/GCP/GLP.6. Submission of Clinical Study Reports (CSR) to Regulatory Authority for Market Authorization as per guidelines.7. Registration of IEC, ICSCR and other licenses/ accreditations owned by the company8. Annual report/ progress report submission to various licensing authority9. Attend SEC meeting for approval of the product10. Preparation of the presentation of the product for Regulatory authorityResearch & Development:1. Registration/ renewal of DSIR for R&D lab2. Submission of research projects to IEC & ICSCR for approval3. Support in pre-clinical testing4. Arrange IEC & ICSCR meeting and perform related functions5. Annual update of R&D activity to concerned authority.Government Funding:1. Submission of proposal to various government agencies for funding2. Communicate with various department for submission of the documents3. Timely update to the agency for progress report of the project4. Resolution of the queries generated by the agency5. PPT preparation to present to the agencyMedical Marketing:1. Preparation of presentation for Doctors for various indications2. To help out the marketing team for data management activity3. Follow-up with the patients after the treatment4. Preparation of product manuals, Investigator Brochure, Product monograph5. Daily update the commercial sheet and raise the issues if any.Preferred- Should have thorough knowledge of Indian FDA System esp. the Drugs and cosmetics Act and all CDSCO related.,

Keyskills :
clinical trialssite managementsitedocumentationcro managementproblem solvingdata integrityclinical researchdocument reviewcase report formssite initiationclinical datadata managementstudy reportson sitegcpelectronic data capturestandard o