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Clinical Study Team Assistant I

Parexel International Corporation

Multiple Locations

Clinical Study Team Assistant I (CSTA I) - Remote- Mexic

Position Purpose:

The Clinical Study Team Assistant I (CSTA I) is an essential part of the Core Study Team and is responsible for 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, which enables the efficient execution of clinical trials to high quality standards.

Organizational Relationships: Reports to Parexel FSP assigned Line Management with day-to-day direction from Client. Refer to Organizational Chart for details regarding assigned role and associated reporting structure.Partners with the Clinical Study Team Lead (CSTL) in providing study level operational leadership and support to clinical study teams.Collaborates with global cross functional study team members of varying levels of seniority to ensure completion of tasks.

Primary Responsibilities: Provides study level operational support to the Core Study Team from study start up to close out and submission with general direction:Management and oversight of Study Team shared spacesTMF maintenance, compliance, and oversightAnalyze, interpret, and follow up on metricsManagement and oversight of Study Management PlatformAnalyze, interpret, and follow up on metricsRegistry 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 Meetings                                       Provides status updates on key tasks and activities to the CSTL and contribute to the Core Study Team Meetings as an active Core Study Team memberWorks proactively with minimal oversight to coordinate and prioritize multiple key study tasks in support of clinical trial systems and processesUses established procedures and methodologies to ensure the completion of assigned tasks according to timelines and to required quality standardsOn occasion, supports short term Clinical Operations Special Project requests (e.g. workstreams, initiatives, projects)Manages conflicting priorities to ensure excellent support to assigned study teams with general directionManages 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 training.Adheres to EP and Client SOPs and processes

Education and Certification: Bachelor’s Degree (B.S or B.A) with 0 to 3 years’ experience or Master’s Degree (M.S, M.A or M.B.A) with 0 to 1 years’ experience

Skills and Experience: Proficient in Microsoft office applications (Outlook, Word, PowerPoint, Excel, TEAMS)Relevant clinical research or clinical trial experience or relevant coursework in drug development or clinical research.

Preferred Qualifications:Science backgroundExperienced with clinical trial applicationsEffective verbal and written communication skillsAbility to work independently but also as part of a larger team with limited support from supervisorAbility to multitask and manage multiple competing prioritiesHas fundamental knowledge of the principles and concepts related to the CSTA roleSelf-motivated and ability to organize tasks to ensure timelines are met and deliverables are of high qualityKnowledge of drug development processAttention to detail evident in a disciplined approach to document review, adherence to SOPs, metrics, etc.Good problem solving & decision-making skills: Ability to work in ambiguous situations within the team to identify and resolve complex problems; Seek input from others when faced with a difficult situation; Make sound decisions within the scope of responsibility; Focus on resolving problems

CSTA I_JD                                                                                                      

Language Skills: Proficiency in written and spoken English

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Job posted: 2023-01-27

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