Clinical study team assistant ii, fsp
-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 which enables the efficient execution of clinical trials to high quality standards
- job description
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 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
- liaising with cross functional study team members:
- provide study level reporting to support management of clinical trial data, clinical trial budget and timelines
- 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 updates on key tasks and activities to the cstl and contribute to the core study team meetings as an active core study team member
- works proactively and independently to coordinate and prioritize multiple key study tasks in support of clinical trial systems and processes
- ensures the completion of assigned tasks according to timelines and to required quality standards
- serves as subject matter expert or technical resource for key clinical trial processes, systems and tasks
- on 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 hires
- mentor new hires and junior cstas
- serves as subject matter expert for key csta processes, systems and tasks
- works with csta managers to identify continuous improvement opportunities to enhance operational efficiencies
- independently manages conflicting priorities to ensure excellent support to assigned study teams
- manages 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 parexel, as necessary, including general training requirements, sops, system, and process related training
- adheres to parexel and client sops and processes
*education and certification*:
- bachelor’s degree (b.s or b.a) with minimum of 3 years’ experience or master’s degree (m.s, m.a or m.b.a) with a minimum of 1 years’ experience
li-remote