Anu Grover, Ms Email and Phone Number

▪ Coordinate administrative and clinical aspects of multiple research projects.▪ Coordinate comprehensive execution of assigned protocols compliant with research governing entity, sponsor, FDA and IRB requirements.▪ Ensure the department’s compliance with applicable regulations and standards.▪ Assist with response (CAPA reports) and preparation of audits.▪ Assist with recruitment, selection and monitoring of research project participants.▪ Review the eligibility of the patient and register the patient on the clinical trial.

• Manage and lead the data management requirements for all GI, Melanoma and Sarcoma oncology clinical trails.• Complete paper and electronic case report forms (CRFs) and resolve queries issued by the sponsor.• Understand the protocols and data submission guidelines for each trial.• Organize and lead site initiation visit for the future trials and monitoring visits for the existing ones.• Work with physicians and nurses closely to assure that the trial is conducted in accordance with SOPs, GCP guidelines, sponsor guidelines and current regulations.• Manage over 125 patients data on different oncology clinical trials (on-treatment and follow-up).• Provide mentorship and training on the clinical trial and data management process to staff members.• Design the CRFs for the clinical trials conducted by the principal investigator(s) at University Hospitals Case medical center.• Design source document forms for nurses to record the important information during the treatment visit.• Create Data Management plans for investigator initiated studies.

• Work in clinical research setting in collaboration with research and clinical faculty.• Designed and developed a quality control GUI for the physicians and technicians to validate the blood flow estimation for research purposes.• Present results and interact with external collaborators and potential future collaborators• Contributed in performance evaluation of the Ingenuity TF PET/CT scanner at the University hospitals using NEMA standards.• Gained knowledge in implementation of pharmacokinetic models and parameter estimation.• Performed phantom experiments on the PET scanner.• Maintained records of experiments, archive data and results.• Reconstructed PET images, analyzed phantom and human PET data quantitatively using MATLAB.• Trained in CITI Health Information Privacy and Security (HIPS) for clinical investigators course.• Performed monthly survey reports on the radionuclide use area in the laboratory.