• Maintains effective communication with study sponsors, investigators, and site staff, addressing inquiries and concerns promptly.• Plays an active role in risk management and mitigation strategies to ensure the successful and ethical conduct of clinical trials.• Contributes to study meetings by providing insights, updates, and recommendations to enhance study conduct.• Assists in reviewing and analyzing study data, identifying trends, discrepancies, and potential issues.• Monitors subject enrollment, data collection, and adverse event reporting to ensure compliance with study protocols.• Participates in co-monitoring visits to assess the performance of junior staff and provide constructive feedback.• Conduct on-site and remote monitoring visits to ensure investigational sites maintain adequate resources and staff for study conduct.• Collaborate with investigators to verify their qualifications, facilities, and equipment for conducting the study.• Ensures that all documentation, including case report forms, source documents, and regulatory documents, are accurate and complete.• Stays current with industry regulations, guidelines, and best practices, applying knowledge to optimize clinical trial operations.• Assists in the development and improvement of standard operating procedures (SOPs) and work instructions.• Handles and resolve issues related to data quality, site performance, and compliance, escalating as necessary.

• Oversaw protocol, regulations, and compliance training; ensures training is up to date.• Applied trial management expertise to oversee overall integrity of the study and problem-solving skills to promote positive working relationships with the site and staff.• Conducted qualification visits (QV), site initiation visits (SIV) and monitoring visits (MV) at assigned clinical sites; generates visit/contact report.• Reviewed the performance of the trial at designated sites, ensuring the rights and well-being of human subjects are protected and are in accordance with protocol.• Evaluated the quality and integrity of the reported data, site efficacy, and drug accountability.• Developed patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines.• Ensured compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s).• Monitored completeness and quality of Regulatory Documentation and performs site document verification.• Tasked with the responsibility of site assessments, pre-trial assessments, site initiation, subject recruitment and retention, monitoring and close-out.• Scheduled staffs for subjects visit.• Works to ensure enrollment goals of the study center are being met.• Supports the team and investigators in overall conduct of the trials.• Follows the established monitoring SOPs, both corporate and clinical, as well as protocol for specific monitoring plan.

• Reviewed research and study regulatory documents required for the implementation, monitoring, and evaluation of clinical trials.• Verified site qualifications and capabilities to conduct clinical studies.• Ensured Trial Master File was accurate and complete throughout the lifecycle of the project.• Prepared and conducted site and CRA training for assigned clinical trials.• Assisted with site audits and site quality management activities as needed.• Maintained current knowledge of GCP and FDA guidance as it relates to clinical research, as well as current clinical related developments in the assigned therapeutic areas.• Designed protocol-specific manuals, plans, and documents as needed.• Ensured that monitoring activities (remote and on-site) are completed in accordance with company/client SOPs and Clinical Monitoring Plan.• Conducted on-site and remote study monitoring and site management.• Assisted project manager with clinical study planning and management, as required.• Developed and maintained positive relationships both internal and external to projects, including clients, team members, and site personnel (PIs, Study Coordinators, etc.).

• Assisted in patient Recruitment and Scheduling.• Identified, recruited, and scheduled patients who may be eligible to participate in the oncology clinical research program.• Performed the initial assessment of potential patient participants, including but not limited to taking detailed clinical history, performing physical exam, and completing patient data forms.• Conducted research tests and supervises exercise training sessions.• Provided potential patient participants with study information.• Obtained informed consent forms.• Acted as the initial clinical resource and liaison between physicians, nurses, and laboratory personnel.• Responsible for data management and data analysis.• Ensured data entry is accurate and completed in a timely manner.• Responsible for the initiation, organization, and handling of patient follow-up.• Assessed and analyzed patient monitor data at all follow-up visits.