Karoline Wentz Email and Phone Number

Home Based Senior Clinical Research Associate with over six years of experience in monitoring clinical Home Based Senior Clinical Research Associate with over seven years of experience in monitoring clinical trials and optimizing results to best benefit Sponsor (around 13 years of clinical trials experience - since as study coordinator). Strong eye for detail and an exceptional ability to follow instructions. Experienced in monitoring multiple site locations (On Site / Off Site – FFPM/RBM model), feasibility, clinical site evaluation, initiation, maintenance and close-out visits in accordance with GCP and company SOPs while ensuring integrity of study data and following study timelines (On Site / Off Site). Skilled in applying applicable clinical research regulatory requirements such as GCP and ICH guidelines. Clear awareness of diverse backgrounds, alert to widely varied patient needs and circumstances. Collaborative team player, acting as Lead Monitor and as key resource to colleagues (Trainer – Mentoring). Consistently meet/exceed expectations, combining driving results with quality improvements and customer service. Skilled in addressing and resolving protocols’ problems and maintaining high levels of satisfaction of Sponsor alike. Ability to build great relationships with Site Staff. Being extremely neat, reliable, greatly motivated, able to deal with complicated projects, creating high quality and timely working results. Previously, over seven years, supervised and coordinated trials while successfully maintaining all protocols and processes of communication demanded by the project’s terms. Therapeutic Areas of expertise: Oncology (Breast, Gastrointestinal, Urothelial, Melanoma, Hepatic, Ovary, Bladder, Prostate), Hematology (Lymphomas, Leukemias) Arthritis Rheumatoid, Kidney/Liver Transplantation, Hospital Infection (Aspergillosis, Candidiasis), RSV (pediatric study).