Responsible for overseeing and managing the overall conduct and operational activities of one or more multi-center clinical research studies in compliance with the protocols, SOPs, FDA regulations and ICH/GCP guidelines. Oversees and participates in the development, implementation, and maintenance of clinical research documents including protocols, informed consent forms, case report forms, and study specific materials. Assists in the generation of INDs, annual reports and other study status reports. Provides support to Investigators and site personnel. Tracks progress of clinical studies and coordinates the monitoring and management of the study to complete deliverables.

Provides clinical research deliverables for new product development programs for device and drug combination products, drug products, and/or device products in an FDA regulated environment with excellent brand and quality reputation. Coordinates Prepares clinical protocols, study documentation, standard operating procedures, risk management plans, monitoring plans, protocol specific instructions, and clinical reports. Coordinates safety management plans, clinical trial agreements, clinical trial management, and site personnel training.

Develops study documentation, qualifies site(s), investigator(s), and/or Contract Research Organisations, oversees clinical study conduct, and provides quality assurance on pharmaceutical and device trials.

Provides clinical research deliverables for new product development programs in the Drug Delivery Systems Division. Coordinates clinical trial management including safety management plans, clinical trial agreements, study specific plans, and site personnel training. Prepares clinical protocols, study documentation, and clinical reports.

Working in the Mayo Clinic Comprehensive Cancer Center, Department of Hematology as a Clinical Research Coordinator. Responsible for study participant enrollment, participant tracking, FDA compliance, in adherence to study protocol in clinical drug trials. Studies are weeks in duration and open and caring communication with study participants is an important aspect of this position. Currently working on nine different interventions funded by the National Cancer Institute, Mayo Clinic, and Industry sponsors. Have completed several training experiences at Mayo Clinic and nationally.

Working as clinical research assistant on several grant funded projects including a multidisciplinary intervention for obesity treatment, a quality of life project for cancer patients, and nicotine dependence interventions. Responsibilities include participant recruitment and scheduling, completion of study visits, data entry, monitoring, and assistant with protocol management.

Researched and created content on critical illnesses for the Ask Mayo Clinic Nurse Line. Part of a multi-disciplinary healthcare team that provides web-based guidance to clients to find appropriate healthcare and information on critical illness that effect the clients themselves or their family members. Content areas focused on aphasia: overview, rehabilitation, adaptive technologies, and resources.

Provided technical assistance, data entry, and statistical responsibilities to a community based participatory research project, funded by the National Institute of Health: Nation Heart, Lung, and Blood Institute (ROI HL 111427). Research based on improving the health of immigrant families in the community through exercise and nutrition interventions.

Completed literary searches and co-wrote published article, including adjusting to a bone marrow transplant and coping with a cardiac event, in the psychology department. Also entered data for various studies relating to health psychology. Traveled to Bethel, Alaska to provide guidance to adolescents who were participants in a study examining smoking cessation for Native Alaskan youths. Project was funded by the National Cancer Institute and involved a weekend on-site retreat and smoking intervention for the youths.