Associate Clinical Research Associate

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Parexel

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Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+

💰 Venture Round on 1990-01

Description

• Attend all training activities organized for this role (in the country or at international level) • Complete all mandatory trainings in LMS • Do all pre-work that applies to each training activity • Complete and deliver on time all activities including post-training activities • Attend all on-going, relevant trainings, including Continuing Education Workshops (CEW) that are applicable • Learn to work in compliance with ICH-GCP Guidelines, applicable international and local regulations, Parexel SOPs, other Parexel and study specific procedures and requirements • Show commitment and consistently perform high quality work • Learn to build relationships with investigators and site staff, including participation in calls with sites • Be able to identify and understand essential documents required for a clinical trial • Be present and support all start-up activities including EC/IRB • Understand the submission process for Site Regulatory Package (SRP) documents collection and follow-up • Being involved in issue identification, follow-up and resolution. • Be able to identify and evaluate potential quality issues. • Attend remote observational visits as requested • Learn about the practical use of the Clinical Trial Management System (CTMS) and any other relevant internal systems • Arrange on-site observational visits and logistics (e.g. travel arrangements). • Perform on-site observational visits (Qualification, Initiation, Monitoring and Termination) with appropriate support; apply judgment and knowledge to independently resolve site issues, questions and concerns. • Work with the mentor in the visit report and follow up letters writing activities. • Successfully pass all assessments related to this role • Complete routine departmental administrative tasks in a timely manner (e.g. times, metrics, concur etc.) • Attend to all internal activities and corporate meetings • Perform project specific training agreed to understand the main project activities • Ensure the basic understanding of project scope, milestones,budgets, and time codes and strive for high quality, timely, and efficient delivery • Help the local team in completing Clinical Trial Management Systems (CTMS) and study specific trackers • Track, scan, code and apply naming convention and send documents to the relevant study e-CF Work In Progress (WIP) area and Central File (CF) area of PMED as per the Central File Maintenance Plan, if applicable • Filling and Archiving paper wet-ink documents in the Central Files office location as per the Central File Maintenance Plan (CFMP) if applicable • Assist with the creation and completion of the Investigator Site File if applicable • Support in on-site / remote visits preparation and follow-up if applicable

Requirements

• Ability to interact professionally within a client organization with the support of manager or team members • Flexible and positive attitude with respect to work assignments and new learning • Ability to manage multiple and varied tasks with enthusiasm • Attention to detail • Willingness to work in a matrix environment and to value the importance of teamwork • Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word • Sound interpersonal, verbal, and written communication skills • Sound proactive and problem solving 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 daily metrics, team objectives, and department goals • Shows commitment to and performs consistently high quality work • Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned • Willing and able to travel locally and internationally occasionally as required. • Holds a driver’s license where required.