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.