Research Coordinator
Há 6 dias
This role is an essential part of the Core Study Team, responsible for supporting key clinical trial tasks for assigned studies to ensure compliance with ICH-GCP, SOPs, and regulatory regulations. The Clinical Study Team Assistant (CSTA) collaborates with global study team members to manage various tasks from study start-up to study close-out, ensuring efficient execution of clinical trials to high quality standards.
Responsibilities- Provides operational support to the Core Study Team by managing Study Team shared spaces, TMF maintenance, compliance, and oversight, as well as registry and/or Clinical Trial Management system(s) compliance and maintenance.
- Liaises with cross-functional study team members to initiate and coordinate completion of study-level forms and data entry into various clinical operations applications and systems.
- Tracks and oversees study-level information, follows up with functional lines as needed, and provides study-level reporting to support management of clinical trial data, timelines, and budgets.
- Ensures quality control of essential clinical trial, Clinical Study Report (CSR), and regulatory submission documentation.
- Manages engagement of Independent Oversight Committees, assists the CSTL and Clinical Quality Lead with Inspection Readiness Activities, and supports short-term Clinical Operations Special Project requests.
- 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).
- 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.
- 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.
- 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.
- Proficiency in written and spoken English.
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