Clinical Research Associate

Responsibilities:

• Manage assigned investigative sites and conduct pre-study site initiation, interim and close-out monitoring visits.
• You will perform source data verification and source data review to ensure data accuracy, completeness and timeliness.
• You will support timely data entry, query resolution and audit readiness while identifying and escalating protocol deviations, safety issues and data risks.
• You will ensure that investigational sites comply with ICH GCP local regulations, study protocols and standard operating procedures.
• You will verify adverse event and serious adverse event documentation and ensure safety reporting is completed within required timelines.
• You will work closely with medical monitors and safety teams to support case reconciliation and safety oversight.
• The role includes responsibility for investigational product accountability, including proper storage, handling, dispensing, documentation and reconciliation.
• You will also support site staff through training on protocols, study systems and operational workflows.
• You will participate in study start-up activities, including site feasibility qualification and readiness assessments.
• During study closeout you will support regulatory completion, archiving and site closure activities.
• Accurate documentation and reporting in electronic trial master file systems is required.
• You will collaborate with project managers, data management safety teams, start-up specialists and other clinical research associates.
• You may support junior CRA development through mentoring or co-monitoring when required.

Requirements:

• A bachelor's or master's degree in life sciences, pharmacy, nursing or a related field is required.
• Candidates must have four to seven years of direct site monitoring experience across clinical trial phases.
• Experience in oncology or other therapeutic areas such as infectious disease vaccines, cardiovascular, central nervous system or endocrinology is an advantage.