both sponsor and investigator sites. ACCOUNTABILITIES: Provide expertise in GCP compliance interpretation, consultation... and provide GCP compliance technical support during inspections of investigator sites and Client. Facilitate appropriate...
with other therapies, including study design, regulatory engagement, and investigator collaboration Partner across functions to define..., and ethical standards Lead the development and execution of clinical protocols, amendments, investigator brochures, study reports...
successful candidate will work directly with the Principal Investigator and a team to study the neurological effects of brain infection... in collaboration with Principal Investigator Reviews results and suggests modifications to experiments and protocols where necessary...
goals Identifies and facilitates investigator-sponsored research aligned with Puma's medical strategies; facilitates...
successful candidate will work directly with the Principal Investigator and a team to study the neurological effects of brain infection...
projects in clinical development. Key Duties and Responsibilities: Leads the development of Study Protocols, Investigator...
, policies and practices related to job area. Job Overview This position reports to the Principal Investigator and provides...
in alignment with sponsor guidelines. Provides regular budget updates to Principal Investigator(s). Processes expense adjustments...
successful candidate will work directly with the Principal Investigator and a team to study the neurological effects of brain infection...
and Medical Affairs for the Investigator Sponsored Studies (ISS) program Maintain HCP and institutional profiling...
Affairs for the Investigator Sponsored Studies (ISS) program Maintain HCP and institutional profiling and visitation records...
Affairs for the Investigator Sponsored Studies (ISS) program Maintain HCP and institutional profiling and visitation records...
and Medical Affairs for the Investigator Sponsored Studies (ISS) program Maintain HCP and institutional profiling...
documents (e.g., Investigator's Brochures, NDAs) and ensure high-quality medical content in Clinical Study Reports. Manage...
company-sponsored and investigator-sponsored studies (ISS), as requested from time to time · Assimilate, process, and share...
protocols, informed consent forms (ICF), investigator brochures (IB), annual safety updates, study reports, and regulatory... meetings, such as Investigator Meetings, KOL meetings, Data Monitoring Committee meetings, for investigator meetings, CRO/CRA...
Affairs for the Investigator Sponsored Studies (ISS) program Maintain HCP and institutional profiling and visitation records...
. Develop materials for and organize investigator meetings, steering committees, and independent data monitoring committees...
, supporting cooperative group, commercial, and investigator-initiated studies. Collaborate in innovative, interdisciplinary...
lifecycle, from initiation to completion, to meet research objectives. Grant Support: Assist the Principal Investigator (PI...