Key Accountabilities:

• Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH GCP guidelines.
• Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites.
• Reviews and verifies accuracy of clinical trial data collected, either on site or remotely.
• Provides regular site status information to team members, trial management, and updates trial management tools.
• Completes monitoring activity documents as required by SOPs or other contractual obligations.
• Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues.
• Escalates site and trial related issues per SOPs until identified issues are resolved or closed.

• Performs essential document site file reconciliation. • Performs source document verification and query resolution.

• Assesses investigational product (IP) accountability, dispensation, and compliance at the investigative sites.
• Verifies SAE reporting according to trial specifications and ICH GCP guidelines.
• Communicates with investigative sites.
• Updates applicable tracking systems.
• Ensures all required training is completed and documented.
• Serves as main observer/assessor of site activities.
• Facilitates audits and audit resolution.
• To undertake other reasonably related duties as may be assigned from time to time as appropriate for experience and as required e.g., protocol amendment submissions, Investigator site budget negotiation.

Skills:

• Proven organizational and presentation skills.
• Ability to manage multiple tasks and meticulous attention to detail.
• Agile & quick learner, good team player
• Willingness and ability to train others on study administration procedures.
• Excellent written and verbal communication skills.
• Good written and spoken English.
• Computer Proficiency: ability to handle daily work via Microsoft Word, Excel, Power Point, and Outlook, etc.

Knowledge and Experience:

• 1 - 2 years clinical monitoring experience required. CRAs with less experience may be considered based on level of mentoring available.
• Read, write, and speak fluent English; fluent in host country language required.
• Oncology experience preferred.
• a licensed healthcare professional (i.e., registered nurse); or equivalent work experience required.

Education:
Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution.