In Parexel FSP we are currently looking for a Clinical Study Team Assistant II to join our team in Mexico. The position will be remote.
The Clinical Study Team Assistant II (CSTA II) is an essential part of the Core Study Team and is responsible for driving and/or supporting key clinical trial tasks for assigned studies to ensure compliance with ICH-GCP, SOPs, and regulatory regulations. The role collaborates with global study team members and is responsible for multiple tasks that span from study start-up to study close-out, enabling the efficient execution of clinical trials to high quality standards.
Responsibilities: Provides study level operational support to the Core Study Team from study start up to close out and submission:Management and oversight of Study Team shared spacesTMF maintenance, compliance, and oversightAnalyze, interpret, and follow up on metricsManagement and oversight of Study Management PlatformRegistry and/or Clinical Trial Management system(s) compliance and maintenanceTracking and oversight of study level information; follow up with functional lines as neededLiaising with cross functional study team members:Initiate and coordinate the completion of study level forms and data entry into various clinical operations applications and systemsProvide study level reporting to support management of clinical trial data, clinical trial budget, and timelinesQuality Control (QC) of essential clinical trial, Clinical Study Report (CSR), and regulatory submission documentationManages engagement of Independent Oversight CommitteesProvides support to the CSTL and Clinical Quality Lead with Inspection Readiness ActivitiesAssists the CSTL with oversight and tracking of Clinical Trial Budget spendProvides logistical/operational support to Study Management for Investigator MeetingsProvides status updates on key tasks and activities to the CSTL and contributes to the Core Study Team Meetings as an active Core Study Team memberWorks proactively and independently to coordinate and prioritize multiple key study tasks in support of clinical trial systems and processesEnsures the completion of assigned tasks according to timelines and to required quality standardsServes as Subject Matter Expert or Technical Resource for key clinical trial processes, systems, and tasksOn occasion, supports short term Clinical Operations Special Project requests (e.g. workstreams, initiatives, projects)Provides support to CSTA Managers for development and implementation of on-boarding training for new hires:Provide training to new hiresMentor new hires and junior CSTAsWorks with CSTA Managers to identify continuous improvement opportunities to enhance operational efficienciesIndependently manages conflicting priorities to ensure excellent support to assigned study teamsManages own time to meet agreed targets; develops plans for short-term work activities on own projects (timelines, work plans, deliverables)Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, system, and process related trainingAdheres to EP and Client SOPs and processesEducation: Bachelor's of Science degree or equivalent and 3 years' experience within the CRO/Pharmaceutical industry.Skills and Experience: Proficient in Microsoft office applications (Outlook, Word, PowerPoint, Excel)Relevant clinical research or clinical trial experience or relevant coursework in drug development or clinical research.Language Skills: Proficiency in written and spoken English
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