*parexel fsp* is hiring multiple *clinical study team assistants* in *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