• Contribute to site identification and feasibility activities.

• Responsible for all aspects of study site management. (e.g. Training site staff, ensure supply of study material, IMP and trial documents, recruitment updates, etc...).

• Responsible for collection and assessment of essential documents and perform reconciliation of Investigator Site File.

• Conduct pre-study visits, site initiation visits site monitoring visits and site closeout visits per SOPs/WPDs.

• Assesses IP accountability, dispensation, and compliance at the investigative sites.

• Prepare accurate and timely visit reports in accordance with the monitoring plan and/or SOPs.

• Collaborates with project functional leads as needed.

• Attends internal and external project calls as requested and per budget to proactively provide required site updates.

• Demonstrates working knowledge of applications and Systems (e.g. CTMS, eTMF, IVRS/IWRS and EDC).

• Facilitates site audits and audit finding resolutions.

• May supervise work of, or mentor, less experienced CRAs, based on Mentoring program.

• Serve as an observational visit leader.

• Provide feedback to management and cross-functional study team on any current or potential risks or problems affecting the conduct of the clinical trial.

• Feedback on any areas requiring improvement within the department and involvement in initiatives such as updating SOPs, Work instructions and Processes.

• Can be involved in other tasks as assigned by Management, CTMs and PMs.

• Escalate in timely manner any issue related to Quality or Data integrity.

• Bachelor’s degree in Nursing, Life Sciences or Medical Sciences or equivalent work experience required

• Previous experience as a Clinical Research Associate with strong demonstration of Clinical Research fundamentals

• Good experience in CTMS, eTMF IXRS and EDC systems

• Previous CRO experience

• Excellent communication skills

• Strong presentation skills

• Proficiency in written and spoken English; fluent in host country language

• Good knowledge of regional clinical research regulations and ICH-GCP

• Multiple therapeutic experience and proven ability to gain in-depth protocol knowledge

• Ability to establish/maintain good relationships with sites/colleagues/clients

• Ability to make decisions independently / Strong problem-solving skills

• Highly developed mentoring and motivational skills