The scope of responsibilities:
1. This position is expected to work collaboratively across functions to support and implement activities associated with assigned clinical study (ies);
2. Deliver study level goals/deliverables with supervision;
3. Deep understanding and familiarity with assigned study and protocol requirements.
Support all study related activities including:
1. Protocol writing, amendment, informed consent;
2. Provide study related data to support regulatory documents (IB, regulatory documents, etc.);
3. Site and CRA training;
4. Site selection and activation in collaboration with clinical operation;
5. Collaborate with the clinical operation to define study activities, deliverables, instructions relating to assigned studies (e.g. IVRS, central lab, site monitoring plan, lab manual, etc.);
6. Support investigator meeting, DMC meeting, thought leader interactions with minimum supervision;
7. Collaborate with CRP and data manager to develop Data Review Guideline;
8. Provide disciplined data review per Data Review Guideline to ensure high-quality data of the study on an ongoing basis.
Education/Working experience requirements:
1. Degree in life sciences (medicine, pharmacy, biology, etc.); 0-3 years of working experience in clinical research/development or equivalent;
2. Advanced degree (Medical Degree or master degree) and/or experience in Clinical Oncology preferred but not required;
3. Demonstrated interests in clinical research;
4. Committed to learn and grow in a dynamic team environment.
Knowledge& Ability requirements:
1. Acquire the ability to interpret and analyze data to support study needs;
2. Acquire the ability to develop proficiency in applying data reviewing tools (excel, JReview, RAVE, etc.);
3. Develop working knowledge in ICH/GCP and drug development including statistics, disease, competitive landscape, and compounds.