Clinical Research Physician - FSP (Immunization)

Position Overview

This role is responsible for providing medical expertise and support throughout the lifecycle of clinical trials, with a focus on immunization studies. The position involves medical document review, safety monitoring, data evaluation, and communication with stakeholders.

Employment Type

• Full-time

Work Schedule

• Standard (Monday-Friday)

Environmental Conditions

• Office

Responsibilities

1. Medical Documentation: Responsible for writing and reviewing clinical trial-related medical documents, including but not limited to:
   • Clinical research and development plans
   • Clinical trial protocols
   • Informed consent forms
   • Investigator manuals
   • Medical reviews
   • Clinical trial summary reports
   • IND application and NDA application related documents
2. Medical Monitoring & Safety Evaluation:
   • Provide medical monitoring for Phase I-III clinical trials, including data review, protocol violation judgment, and investigator communication.
   • Responsible for safety evaluation, SAE/AE review, and other medical support.
3. Training & Communication:
   • Provide professional training on diseases, products, and study protocols to clinical research team members and other relevant stakeholders.
   • Participate in internal and external communication and discussions related to clinical trials.
4. Drug Development & Research:
   • Responsible for the evaluation and research related to the development of new drugs or the introduction of medicine.
   • Responsible for the writing and publication of research papers after clinical research data are generated.

Requirements

1. Education: Master's degree or above in clinical medicine.
2. Experience:
   • Minimum 3 years of project experience in medical monitoring and safety evaluation of Phase I-III clinical trials.
   • Experience with skin immunization projects is preferred.
3. Knowledge:
   • Good understanding of the overall drug development process.
   • Familiarity with clinical trial methodologies.
   • Knowledge of the regulatory environment in China and ICH/GCP guidelines.
   • Understanding of drug registration regulations and processes in related fields.
   • Understanding of medical statistical analysis methods.
4. Certifications: Possess a GCP certificate.
5. Language Skills:
   • Good English communication skills.
   • Basic English reading and writing skills.
6. Interpersonal Skills:
   • Good communication and interpersonal skills.
   • Ability to work well with others, motivate, and encourage others.
7. Performance: Ability to deliver results efficiently and meticulously under pressure.
8. Travel: Accommodating of business travel.

Application Instructions

• [Details to be provided by the applicant]

Company Information

• [Details to be provided by the applicant]