Clinical Study Team Assistant I

**Parexel FSP** is hiring multiple **Clinical Study Team Assistants** in **Argentina, Brazil and Mexico**

The **Clinical Study Team Assistant (CSTA)** 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-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 closeout and submission with general direction:

- Management and oversight of Study Team shared spaces
- TMF maintenance, compliance, and oversight (analyze, interpret, and follow up on metrics)
- Management and oversight of Study Management Platform (analyze, interpret, and follow up on metrics)
- Registry and/or Clinical Trial Management system(s)compliance and maintenance
- Tracking and oversight of study level information; follow up with functional lines as needed
- Quality Control (QC) of essential clinical trial, Clinical Study Report (CSR)and regulatory submission documentation
- Manages engagement of Independent Oversight Committees
- Provides support to the CSTL and Clinical Quality Lead with Inspection Readiness Activities
- Assists the CSTL with oversight and tracking of Clinical Trial Budget spend
- Provides logístical/operational support to Study Management for Investigator Meetings
- Provides status updateson key tasks and activities to the CSTL and contribute to the Core Study Team Meetings as an active Core Study Team member
- Works proactively with mínimal oversightto coordinate and prioritize multiplekey study tasks in support of clinical trial systems and processes
- Uses established procedures and methodologies to ensure the completion of assigned tasks according to timelines and to required quality standards
- On occasion, supportsshort term ClinicalOperations Special Projectrequests (e.g. workstreams, initiatives, projects)
- Manages conflicting priorities to ensure excellent support to assignedstudy teams with general direction
- Manages own time to meet agreed targets;develops plans for short-term work activities on own projects (timelines, work plans, deliverables)
- Completes training assignedby Client and/orEP, as necessary, including generaltraining 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 1 to 3 years’ experience in pharma or CRO or Master’s Degree (M.S, M.A or M.B.A).

**Skills and Experience**:

- Relevant clinical research or clinical trial experience or relevant coursework in drug development or clinical research.

**Preferred Qualifications**:

- Science background
- Effective verbal and written communication skills
- Ability to work independently but also as part of a larger team with limited support from supervisor
- Ability to multitask and manage multiple competing priorities
- Has fundamental knowledge of the principles and concepts related to the CSTA role
- Self-motivated and ability to organize tasks to ensure timelines are met and deliverables are of high quality
- Knowledge of drug development process
- Attention 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

**Language Skills**:

- Proficiency in written and spoken English

LI-REMOTE