This position will work closely with a cross-functional team to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets.
Collaborate with the statistics, data management teams and enrolling centers to resolve outstanding forms and data queries; all site contacts regarding late forms or highly queried forms will be made by Coordinating Center staff using information provided by the statistics and data management teams.
The Clinical Research Associate (CRA) is responsible for providing support to the Clinical Development management team, clinical tracking and document maintenance as applicable to study vendors and clinical trial sites.
Design high quality CRFs in collaboration with a cross functional team that are clinically meaningfully, accurately reflect the data collection requirements identified in the study protocol, and consistent with internal standards.
Prepare clinical-related documents with minimal supervision and routine documents independently as directed. Examples include, protocol synopses, protocols, CRFs, and supporting work for regulatory
submissions such as INDs.
The Clinical Scientist serves a medical research function and applies a broad knowledge of clinical research activity, therapeutic area knowledge and regulatory requirements to facilitate the development and implementation of clinical studies.