ICON Strategic Solutions
Location
Kolkatta | India
Job description
Clinical Research Associate II / Senior CRA - Cardiology
The Clinical Research Associate is the person in Trial Coordination and Site Management that serves as primary contact point between the sponsor and the investigational site. This position is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through database lock. Responsibilities include site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, monitoring and close-out. Partner with the CTA/IDA, LTM and GTM to ensure overall site management while performing trial related activities for assigned protocols. May contribute to process improvement, training and mentoring of other Site Managers. • Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team • Acts as primary local company contact for assigned sites for specific trials. • Attends/participates in investigator meetings as needed. • Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies. • Ensures site staff is trained and the corresponding training records are complete and accurate at any time point during all trial phases. • Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target. • Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct. • Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented. • Arranges for the appropriate destruction of clinical supplies • Ensures site staff completes the data entry and resolve queries within expected timelines. • Ensures accuracy, validity and completeness of data collected at trial sites • Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents. • Maintains complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial Master Source and SharePoint. • Fully documents trial related activities in particular monitoring. Writes visit reports and uploads into eTMF within 5 working days for review and approval. Complete follow-up letter to communicate relevant information and required corrective action to the investigator and his/her team with 15 working days. Promptly communicates relevant status information and issues to appropriate stakeholders. • Follows the corresponding Monitoring Guidelines for each assigned trial. • Reviews TCF for completeness and ensures archiving retention requirements, including storage in a secure area at all times. Experience and Skill Requirement: • Required a BA/BS degree with a minimum of 2+ years clinical trial monitoring experience. • Previous experience monitoring Cardiology clinical trials preferred. • Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines. • Strong IT skills in appropriate software and company systems. • Willingness to travel with occasional overnight stay away from home. • Good written and oral communication skills. ICONSS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry. ICONSS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.Job tags
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