and auditing visits with study coordinator, Investigator, DF/HCC QACT, Industry Sponsors, and third party auditors. Clinical...
an AI-powered, highly personalized email program. You will act as a universal translator, investigator, and product evangelist...
(but not limited to) drafting scientific meeting briefing books, Protocols, Investigator's Brochures, annual reports, clinical and non... of clinical/regulatory document preparation, including protocols, CSRs, Investigator Brochures, and other regulatory submission...
program expenses, including CROs, investigator sites, and other third-party vendors. Contribute to the annual budgeting...
supervision of a principal investigator while developing skills for independent work. (essential) - Receives training...
for key safety-related documents, including: o Informed Consent Forms (ICF) o Protocols o Investigator’s Brochure (IB...
Responsibilities Administrative: Assists principal investigator with protocol development. Assists principal... investigator as appropriate with the Institute’s protocol review process. Assists the principal investigator in developing the...
., Dear Investigator Letter, Informed Consent Form, Investigator’s Brochure, Healthcare Professional REV. 20 MAY 2024 2... investigator training Risk Assessment, Regulatory Inquiries, and Periodic Reporting Analyze safety data and author relevant safety...
sponsor/monitor inspections and clinical investigator site inspections Support vendor selection/qualification activities...
consent, clinical protocols, Investigator Brochure, yearly updates to the regulatory authorities and status updates... and external partners (including investigator and site staff) using collaborative negotiation skills Strong computer skills...
investigator and/or research nurse, submits protocols, amendments, notices, suspensions and terminations to the IRB for review.... Verifies information with clinical research nurse and/or principal investigator. May enroll patients onto clinical trials...
of the principal investigator, conducts a variety of routine experiments using molecular, cell biology and/or biochemistry...
and charges, ensuring appropriate use of funds under investigator control, both in terms of sponsor/external regulations..., performs related duties as assigned. Establishes monthly meetings with the head of each laboratory (Independent Investigator...
Investigator Site Audits, GCP Document Audits, and support Internal Process Audits and Vendor/System audits Draft, review, revise...
and LOC activities. Providing medical review and approval of Investigator Initiated Research (IIR) proposals and other grants...
opportunities and facilitate the conduct of external clinical investigator-initiated trials (IITs) and company-sponsored trials...
Do Under general supervision of Principal Investigator or Project Administrator, The Senior Research Coordinator: Executes protocols...
distribution approval Assist the Clinical Trial Team with the design of presentations Investigator Meeting Compliance...
to establish and maintain professional relationships with external experts, investigator, journal editor, publishers...
), investigator brochure (IB), clinical trial application (CTA), etc) Review associated reports, including clinical, toxicology...