** 2 years of onsite monitoring in Oncology at a CRO or sponsor**
Responsible for evaluating, initiating, monitoring and closing out clinical study sites. Documents all activities in clear, comprehensive and accurate Monitoring Visit Reports, Contact Reports and follow-up letters within required timelines.
Ensures that the conduct of clinical studies at sites is in accordance with the protocol/protocol amendments, Good Clinical Practice regulations, International Harmonization Guidelines, applicable company Standard Operating Procedures (SOPs), and all applicable regulatory requirements.
Properly trains/re-trains site personnel on the protocol/protocol amendments, systems utilized in the study, and all operational aspects of the trial.
Serves as primary contact for site personnel, acting as liaison between site personnel and sponsor study team members.
Develops patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines.
Ensures subjects’ rights, safety and well-being are protected.
Ensures compliance with the procedures to apply in the event of adverse events and serious adverse events.
Evaluates the quality and integrity of reported data, ensuring that sites enter data into EDC and resolve queries in a timely fashion.
Assists and supports data validation and data cleaning procedures to ensure timelines are met.
Identifies, assesses and resolves site performance, quality or compliance problems and develops an appropriate intervention plan for the avoidance of redundant errors and deviations.
Communicates with Investigators, site staff, Sponsor Study Team Members, and/or QA on issues related to protocol conduct, subject recruitment and retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
Maintains audit-ready clinical trial documentation. Collects, reviews, monitors, and files required regulatory documentation during study maintenance and at study closeout. Verifies investigator study records are reconciled with the contents of Sponsor files (Trial Master File).
Verifies the receipt, handling, accounting, storage conditions and availability of study medications under investigation.
Ensures availability of non-clinical materials for sites.
Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
Gains an in-depth understanding of study protocols and related procedures.
