• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.• Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.• Collaborate and liaise with study team members for project execution support as appropriate.• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

-Collaborate on the design and development of Clinical Protocol, Clinical Methodology, and Informed Consent documents.- liaise with Investigators, Investigative Sites, IRB's, and CRO's- Creation and modification of regulatory documents, logs, study binders, training materials.- Participate in the identification and assess the suitability of Investigators and clinical trial sites.- Selection of IRB/Project Management for multi-site trial submissions to regulatory agencies.- Design Case Report Forms (CRFs) and assist data management with Electronic Data Capture System (EDC) build.- FDA IDE submission and response process.- Prepare Clinical Trial Agreement (CTA), Site Clinical Trial Budget, and Investigator Agreements.- SOP creation/modification. - Prepare/Construct/Conduct Site Qualification Visits (SQV) and Site Initiation Visits (SIV).- Ensure the conduct of trial is in compliance with all regulatory and contractual requirements.- Monitor study conduct and progress to ensure compliance with established protocols, appropriate research methodology, and study timelines.- Oversee eTMF activity.- Participate in site training activities and provide ongoing support.

Responsible for screening, recruitment, consenting, and retention of patients into Oncology studies phase I-II-III-IV. •Communicated with patients and health care providers to efficiently adhere to study procedures and Duke University Health System’s Institutional Review Board (IRB) protocol guidelines•Managed accurate records of study information, source documents, adverse events, and patient health information •Performed in data entry and data management •Identified quality and performance improvement opportunities and collaborates with team in the develop of action plans to improve quality •Maintained effective and oncoming communication with research participants and sponsors •Attended start-up and monitoring visits with sponsors and department team •Worked with manager to assist and train new hires •Acted as a lead coordinator for multiple studies, assign work load and ensure proper workflow of the team •Supervised the work of employees in supporting roles, including assigning workload and reporting employee performance •Strong working knowledge of good clinical practice (GCP)•Experience with RedCap, Epic, Oncore, Iris, and general EDC systems