Highly motivated, goal-oriented, and results-driven professional with over 20 years of experience in the pharmaceutical industry. Strong background in the areas of pharmacy and medical device and regulatory compliance.
Recruitment and compensation; monitoring of clinical trials, compliance with ICH/GCP guidelines, SOPs, budgets, and quality analysis.
Develops and implements project plans, including budget management, risk mitigation, contingency planning, and research budget. Oversees the development of the study budgets, and provides oversight of the development of the trial Master file.
Coordinates the development and implementation of the Oncology program and reporting to the Vice President of operations. Ensures that the patient access is being conducted.
Develops and implements study budget and serves as a liaison between the sponsor and the project team. Provides guidance and direction to the project team.
Assists in the development of therapeutic area contracts, coordinates with the project Manager, and provides input to the Vice President of clinical affairs.
Oversees the assessment of study sites, provides guidance and direction to the project team, and other functional areas.
Senior Clinical Research Associate
Premier Healthcare Services
Assist in the development and implementation of the study protocol, including but not limited to, the informed consent document, case report form (CRFs), source documents, CRF design, EDC training and other relevant
Responsible for the conduct of clinical trials in accordance with the monitoring Plan, applicable regulations and GCP guidelines. Develops and maintains effective working relationships with the site, the global Oncology team and the sponsor.
Conduct site initiation visits to ensure that studies are carried out according to the protocol, SOPs, ICH, GCPs and all applicable regulations.
Perform source document verification, retrieve case report forms (CRFs) and perform query resolution in a timely manner.
Responsible for monitoring of clinical trials in accordance with ICH GCP, FDA regulations and SOPs. Conduct training on study procedures.
Responsible for the development and training of clinical trials in accordance with ICH/GCP guidelines, SOPs, and monitoring guidelines.