VerGo Pharma Research Pvt. Ltd. (VerGo Clinicals) Corlim, Goa, India
Jun 22, 2017Full time
1) Develop and review protocol specification for quotes including appropriate design of the study, study protocols and reports 2) Develop a program for pre-study screening, assessment of eligibility criteria, medical care, ADR and AE monitoring and emergency management of ADRs and SAEs. 3) Training Clinical Research Staff for recent trends and advance Develop & review of key Clinical Research documents. 5) Guide and develop the preparation of laboratory reports and scientific papers 6) Overall responsible for organization and conduct of bioequivalence and pharmacokinetic studies in conformance to GCP standards, SOPs, and applicable regulations 7) Ensure that all professional and technical personnel involved in the conduct of the study have job descriptions and records of training, qualification and experience, which support their ability to undertake the tasks assigned to them 8) Review medical records and ascertain eligibility of subjects 9) Review the protocols, informed consent documents and CRFs for all clinical studies Develop project plan in co-ordination with designated personnel Ensure the conduct trials with compliance to SOPs and GCP/GLP requirements Facilitate monitoring and auditing by the sponsor and inspections by any regulatory authorities. Liaison with Ethics Committee for review of study protocols and informed consent documents Directly supervise the activities of clinical staff Ensure proper reporting of adverse events to sponsor / Ethics Committee/ regulatory authorities Ensure reporting of SOP/ protocol deviations in accordance with SOPs Ensure proper volunteer compensation Obtain written informed consent from study subjects Carry out medical examination of volunteers for screening prior to clinical studies or as required Manage medical emergencies internal & external 21) Hold accountability for study drug samples according to GCP guidelines and applicable GMP Requirements Review the final study report of completed studies Impart GCP and other technical training (including protocol training) to study personnel Review SOPs and give inputs, as applicable during SOP development / revisions Maintain awareness in recent trends and newer guidelines in clinical research Compliance to Quality Assurance Unit Queries.