On assignment as Site Care Partner supporting the client’s oncology clinical trials as the main point of contact for investigative sites, driving site start-up activities and ensuring operational success throughout the study lifecycle.• Subject Matter Expert for local/country regulations and operational implementation. • Supports processes to optimize country and site selection activities and leads start-up activities through activation.• Leads site management from start up, conduct, and closeout including patient recruitment planning and delivery.• Acts as operational point of contact for site-level questions, liaising with and escalating to appropriate team members.

Led cross-functional teams (Sales, Professional Services, Technical Services) to identify and implement solutions for top 10 client pain points that improved the customer experience.• Project Managed CRO / Partner account experiences, increasing satisfaction by 10% through health monitoring and improvement initiatives.• Acted as a Subject Matter Expert to acquire new CRO / Partner accounts, driving increased product usage and satisfaction by 10% from standards.• Aided CRO / Partner account adoption for increased product usage through software utilization quality and quantity management tracking.• Developed and executed a risk assessment framework for onboarding new clients, minimizing potential delays and disruptions by 15% from baseline.• Accountable for reporting Service Level Agreement (SLA) metrics to customers derived from Master Service Agreements by analyzing MSAs to identify relevant metrics, such as uptime guarantees and response times to ensure transparency, address concerns, and create concise reports.

Monitored all visit types of clinical trials to ensure adherence to Good Clinical Practice, investigator integrity, and compliance with all study procedures.• Mentored junior CRAs, providing aid and guidance on study tasks, protocol adherence, and site communication.• Supported in data collection, investigator payment reports, and tracked Clinical Trial Agreements (CTAs) and eTMF management.• Performed site management activities, including all in-house and on-site monitoring for all visit types. • Verified qualifications and training of lab personnel performing the tests.• Reviewed protocol laboratory manuals and quality control measures with investigators and site staff for training purposes.

Managed site selection and patient recruitment / retention strategies for successful clinical trial completion. Performed feasibility studies for potential sites.• Conducted pre-study, study initiation, and interim monitoring visits in adherence to protocol requirements.• Mentored individual CRAs, fostering professional development through coaching, on-the-job training, and career path planning.• Conducted source document verification for compliance, patient safety, and veracity of data, ensuring sites were following compliance and patient safety according to Good Clinical Practice.

Devised and executed unique recruitment and retention plans for each clinical site based on their individual capacities.• Conducted pre-study, initiation, routine monitoring, and close-out visits in accordance with protocol requirements and trial monitoring plans.• Managed regulatory documents, approvals, and essential documents, ensuring completeness of site investigator files.• Conducted source document verification and source document review (remote monitoring), along with Risk Based Monitoring activities per ICH GCP (FDA Regulatory Guidelines.• Collected and documented study related documents and essential documents for filing in the sponsor’s electronic trial master file (eTMF).

Promoted to Senior CRA for exceeding annual goals in patient accrual, data quality, and regulatory compliance in oncology trials. Led team of 4 junior CRAs.• Guided, trained, and supported clinical trial processes, regulatory compliance, and data management best practices, improving team's site initiation completion rate by 20%.• Conducted source document verification (radiology reports and pathology records) and source document review (remote monitoring) for oncology clinical trials, ensuring adherence to RECIST criteria and data accuracy.• Tracked progress of clinical trials’ subject enrollment and recommend adjustments on a site-by-site basis, including troubleshooting, analyzing, and reporting progress internally and externally.• Reviewed subject informed consent forms, processes, and confirmed subject safety was upheld.

Served as primary point of contact for the Principal Investigator, physicians, and research staff to manage all aspects of Phase II-IV oncology studies, from initiation (regulatory submissions, informed consent development) to execution (patient recruitment, tumor response assessment using RECIST criteria, imaging data collection and submission) to termination (regulatory reporting).• Coordinated clinical and regulatory document submissions for clinical trial start up, consent development and amendment, protocol amendment, continuing review, closure to accrual, suspension, termination, and other reportable regulatory information.• Helped with lab setup for specific procedures related to Oncology research study protocol.• Prepared specimen and tissue samples for analysis and shipment.