The CRA will be respnsible to: Support the goals of the Oncology BU by initiating, monitoring, and closing out clinical study sites following GCP and ICH guidelines as well as Novartis SOPs and ensuring that study milestones are met. Central point of communication between Novartis and investigational sites for all Oncology clinical trial related activities. Mentor to CRAs. Leader of internal Novartis CRA teams (local and global) when assigned. 1. Serve as a leader and mentor to other CRAs in all aspects of the CRA role. May represent RAD and region at management meetings or other meetings as assigned and participate in decisions made at assigned meetings (e.g. site selection, site issue resolution). May interview prospective CRA candidates and assist with performance evaluation and management of CRAs. 2. Manage assigned study sites and networks conducting phase I-IV protocols according to the monitoring plan including source document verification. 3. Ensure the site Investigator Folder is up to date and mirrors the Novartis TMF. Responsible for collecting regulatory documents from site and filing in the Novartis TMF. Prepare and collect study site documents. 4. Perform Initiation Visit and continue to train study personnel as needed on study protocol, procedures, study drug handling and storage, CRF (or eCRF) completion, SAE reporting, GCP, and possibly the drug mechanism. 5. Conduct feasibility and screen potential Investigators and networks to evaluate their capabilities for conducting clinical trials. Nominate sites to participate in studies in conjunction with Medical Science Liaison (MSL) and National Account Scientific Director (NASD) colleagues. 6. Monitor site drug supply, storage, accountability documentation. Perform interim and final drug return. 7. Responsible for utilizing and updating electronic systems to perform job functions (e.g. Lotus Notes, WinFx, ClinTransfer, IMPACT, IWS, eTMF, webEDI, I.MAN, STARS, Vantage, SSU Database, Investigator Portal, Pathlore, ESOPs, iLearn, Expense reimbursement, CWT Horizon, Metrixx, Timecard, PMP, multiple eCRF applications). Serve as a reference to other CRAs on electronic systems. May be responsible for assisting with the evaluation, design and implementation of new systems.
Bachelors degree or higher in a scientific or health care discipline preferred. A nursing qualification or extensive relevant experience may commensurate. Fluent English (oral and written). 1. Solid medical and business knowledge. 2. At least 3 years of prior oncology and /or hematology experience. 3. Three to five years of experience as a CRA; two years as Novartis CRA preferred. 4. US local Lead CRA experience. 5. Demonstrated ability to coordinate, organize, communicate, and manage site activities, with knowledge of when to escalate issues to management or clinical team. 6. Advanced understanding of clinical development, knowledge and experience in international (FDA, EMEA, ICH) and local regulations as well as Novartis standard operating procedures. 7. Excellent oral and written communication and presentation skills. 8. Computer literacy and proficiency. 9. Ability to multi-task and prioritize multiple high- priority projects, site questions, CRA questions, and clinical team inquiries while managing responsibilities and deadlines.