Clinical Study Team Assistant I, Fsp
hace 2 semanas
Job Description
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 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 with mínimal oversight to coordinate and prioritize multiple key 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, 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 direction
- 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 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**:
- 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
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