Clinical Research Associate

Senior Clinical Research Associate #lifesciencegraduate #nagpurjobs #apportunities #clinicalresearchinstitute #smo #clinicalresearchcareers #clinicalresearchtrials #medicalresearch #healthcare #biology #pharmacovigilance #clinicalresearchtraining #education #bpharma #research #clinicalresearchers #nurse #clinicalresearchjobs #crc #pharmaceuticals #pharma #clinicaltrialsguru #clinicaldatamanagement #cralife #sciences #pharmacy #training #careers #rn #clinicaltrialsday • Assesses site qualification potential: Reviews study requirements; conducts pre-study visits and drafts pre-study evaluation reports. • Participates in the implementation of clinical studies communicates with investigators and their staff; ensures compliance with terms and conditions; properly trains site personnel and writes initiation visit reports. • Supervises the conduct of clinical studies: Visits trial sites regularly. Acts as liaison between project managers and research-site personnel. Maintains the quality of the work and relationships. Monitors the conduct of clinical trials and compliance with established timelines. Performs monitoring in the field; ensures compliance with protocols, regulatory requirements, and good clinical practices; writes follow-up visit reports. Ensures harmonization of in-house monitoring practices. • Ensures the quality of the project verifies materials and data integrity; assists site personnel with internal audits or regulatory inspections; and performs ongoing follow-up with the in-house project team. Adheres to protocol regulatory requirements, good clinical practice regulations, and standard operating procedures. Assesses the trail site and applicable personnel on an ongoing basis. Ensures compliance with the patient-consent process. Verifies the receipt, handling, accounting, storage conditions, and availability of clinical products under investigation. Verifies compliance and quality of collected data. Ensures compliance with procedures to apply in the event of serious adverse events. Drafts an appropriate intervention plan for the avoidance of redundant errors and deviations. Verifies investigator records and checks for consistency with the contents of sponsor files. • Closes Clinical Studies: verifies the integrity of investigator files; ensures availability of clinical and non-clinical materials; jointly reviews with investigators the obligations inherent at the end of the study and writes closure visit reports. • College nursing diploma or Bachelor of health sciences, nursing, biomedical sciences, pharmacy, pharmacology, or a related discipline. • Master’s degree in one of the aforementioned disciplines or another postgraduate degree. • Communication skills and good interpersonal relationships • Minimum of 4 to 6 years of experience in CRA required • Keep knowledge up to date to remain proficient. • Attend symposiums, conferences, and continuing education training. • Proficient in MS Office (Excel, Access, Word, etc.) • Excellent communication skills. • Strong management skills. • Good time management skills