Job Description
61Drive study performance at the sites. Perform site monitoring and other onsite visit activities according to monitoring plan and in compliance with procedural documents. Provide the required monitoring visit reports within required timelines. Proactively identify study-related issues and escalates to Local Study Teams as appropriate.
61Contribute to the selection of potential sites and investigators. Train, support and advise Investigators and site staff in study related matters.
61Obtain and maintain essential documentation in compliance with ICH-GCP, Procedural Documents and local regulations. Manage study supplies, drug supplies and drug accountability at study sites.
61Perform source data verification according to SDV plan. Ensure data query resolution. Work with data management to ensure quality of the study data.
61Ensure accurate and timely reporting of Serious Adverse Events.
61Share relevant information on patient recruitment and study site progress within local Study Team. Update VCV and other systems with data from centres as per required timelines.
61Prepare for activities associated with audits and regulatory inspections in liaison with local Study Team Lead and QA.
61Adherence to client’s Code of Conduct and company policies and procedures.
61Additional tasks assigned by manager, include but not limited: study level tasks associated with Country Study Manager (CSM), act as a mentor for junior team member, co-monitor less experience CRA within study team.
61Contribute to process improvements, knowledge transfer and best practice sharing.
Comply with required training curriculum.
61Complete timesheets accurately as required.
61Submit expense reports as required.
61Update CV as required.
61Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements.