Primary Location India Bengaluru Job ID R0000034693 Category Clinical Trials ABOUT THIS ROLE Job Purpose The role of the Clinical Operations Assistant COA is to maintain the paper and electronic Central Files for Clinical Operation ensuring efficiency accuracy and quality Depending on the location of the role may include the tracking scanning filing entry and return of Case Report Forms to clients for assigned projects upload and naming of documents to the electronic document management system EDC User Management activities and activities associated with Impact Harmony as appropriate COA is also to support all site management team members on local billable administrative tasks and assist with QC of Central files Key Accountabilities Track scan code and apply naming convention and send documents to the relevant study Work In Progress WIP area and Central File CF area of PMED as per the Central File Maintenance Plan Filling and Archiving paper wet-ink documents in the Central Files office location as per the Central File Maintenance Plan CFMP Photocopy print distribute and retrieval of documents as needed Maintain basic quality check procedures to ensure accurate maintenance of documents Tracking maintenance of the Clinical Trial Management System CTMS and study specific site trackers Client additional request only Monitoring of the status of systems and processes e g annual reporting obligations Site Compliance regarding Safety Information System SIS etc to ensure compliance Organization of translations of study document e g contacting translation company requesting approval via Oracle following up with translation company to ensure timely delivery Payment invoice processing including internal follow up with payment specialists in Finance Courier shipment of study document to the sites vender and clients Collection of internal signatures for site documents e g confidentiality agreement or clinical site agreements within PAREXEL Skills Experience working in CROs or Life Sciences industry preferred Support with document collection customization review for clinical trials being conducted in Japan Liaise with sites investigators on assigned projects to facilitate conduct and delivery Work closely with project management teams on all assigned tasks Ensure quality and compliance in all clinical research activities Ability to interact professionally within a client organization Ability to prioritize multiple tasks and achieve project timelines utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise Robust interpersonal verbal and written communication skills Sense of urgency in completing assigned tasks and ability to assist others to meet study country deliverables Effective time management in order to meet study needs team objectives and department goals Knowledge and Experience Site Management experience or equivalent experience in clinical research with understanding of clinical trials methodology and terminology Education Educated to degree level biological science pharmacy or other health-related discipline preferred or equivalent nursing qualification or other equivalent experience