Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Job Summary:
The Senior Compliance Coordinator supports the clinical trial process by ensuring the completeness, accuracy, and timely entry of study data in the eCRF system. This role is responsible for maintaining high-quality documentation and supporting compliance activities across multiple sites and regions. The position involves regular communication with internal teams and external stakeholders, including monitors and sponsor representatives.
Key Responsibilities:
Maintain Investigator Site Files (ISF) and study trackers; verify the correct completion of Informed Consent Forms (ICFs).
Perform timely and accurate data entry from source documentation into the eCRF system.
Track the flow of eCRFs and queries; support query resolution and deviation reporting.
Assist with audit preparation and readiness, and support compliance checks.
Collaborate with monitors and client representatives to clarify expectations and resolve issues.
Identify and escalate data errors and trends, assisting in CAPA and problem-solving activities.
Support archiving and compliance report drafting as needed.
Qualifications:
High school diploma or equivalent with relevant academic or vocational training.
Basic understanding of GCP, ICH, and data protection regulations.
Proficient in MS Office; working knowledge of Business English.
Attention to detail and ability to handle confidential information.
Skills and Abilities:
Ability to work independently and manage multiple studies simultaneously.
Strong interpersonal skills and ability to collaborate across teams.
Familiarity with audit processes and clinical documentation.
Basic understanding of medical terminology and data systems.
