Results-driven clinical research professional with 3 years experience in study grant analysis and a passion for expanding knowledge in new domains. Committed to leveraging strong analytical skills, attention to detail, and robust understanding within the clinical research field. Seeking new opportunities to contribute expertise to diverse projects and drive positive outcomes in a challenging environment.
• Timely preparation of accurate and competitive Clinical Study grants (Phases I – IV for all clinical indications) via proficient usage of any Clinical Study Pricing Tool that PAREXEL is required to use to support our Clients’ needs. The default, currently licensed tool in this regard is Grant Plan.
• Collaborate to prepare competitive budget concepts for Pre-sales business Proposals in conjunction with other members of the Proposal team while remaining compliant with the Request for Proposal (RFP) and PAREXEL internal policies.
• Preparation of additional Post Award Clinical Study grant analyses for the assigned Site Contracts Leader and Study Project Leader and Project Director, as appropriate.
• Ensure that all Clinical Study grant information is performed in full compliance with Fair Market Value (FMV) principles and the Physician Payments Sunshine Act.
I was always interested in clinical trails conducted in Oncology department. I am delegated in few studies which deal with metastatic breast cancer, Early breast cancer, small cell lung cancer and non- small cell lung cancer. I was responsible for coordinating and managing the various aspects of clinical trials. Duties include study start-up, participant recruitment, documentation, participant management, data management, adherence to protocol, investigational product management, collaboration, regulatory compliance, quality control, training, and study close-out. I had a chance to assist in protocol development, site selection, and obtaining approvals. I had a chance to screen and recruit participants and maintain accurate study documentation. Participant management involves scheduling visits, ensuring safety, and collecting data. Data management is crucial for maintaining accuracy and confidentiality. Adherence to protocol and reporting deviations are essential. I have managed investigational products and collaborated with stakeholders. Regulatory compliance and quality control are vital. Training and education are provided, and I have also contributed to study close-out activities.