•    Schedule and conduct routine monitoring visits as per Clinical Monitoring Plans.
•    Assist in identifying, enlisting, and selecting sites, and facilitate site management activities.
•    Review and verify source documentation and electronic case report forms.
•    Track data entry and enrollment timelines.
•    Function as a client representative, recording and sharing interactions.
•    Participate in meetings with investigative sites, key opinion leaders, and consultants as needed.
•    Respond promptly to study questions and issues raised by investigative sites.
•    Gather and examine trial documents.
•    Coordinate with Clinical Trial Managers and research sites to ensure timely progress of clinical trials.
•    Create and implement study-specific clinical monitoring tools and documents.
•    Provide protocol-specific training to Clinical Sites and conduct regular monitoring visits.
•    Plan and schedule site visits.
•    Create monitoring reports and document findings to confirm appropriate conclusions and actions taken.
•    Ensure compliance with SOPs, local regulations, CFR, ICH, and GCP guidelines.
•    Document protocol deviations in monitoring reports and follow-up with sites and investigators.
•    Review serious adverse events and pertinent data with medical monitors and drug safety personnel to identify safety trends and potential risks.
•    Execute other assigned duties.

•    Effective communication skills.
•    Ability to manage priorities and meet deadlines.
•    Strong problem-solving and analytical ability.
•    Adaptability and professionalism.
•    Leadership skills.
•    Planning and organizing capabilities.
•    Capability to provide direction and motivation.
•    Sound judgment.

•    Minimum 2+ years of experience in Clinical Research and/or the pharmaceutical industry.
•    Familiarity with Electronic Data Capture (EDC) systems.
•    Experience with Smartsheet software for collaboration and time management.