Tina KitanoProgram Management Associate

Tina joined JCRO in January 2021 as a Program Management Associate and is responsible for multiple early stage of oncology project. She is also well versed in PV and CRA activities.

As an ICCC (In-Country Clinical Caretaker in Japan) representative, Tina’s role covers process management of the initial CTN (Japan IND) including Japan-specific safety-run-in protocol development – a critical step in the startup of clinical studies in Japan.

Specifically, Tina represents non-Japanese sponsors who have no affiliate in Japan and maintains close communication with local vendors related to each respective project as well as regulators (PMDA).

During her current position as Project Management Associate, Tina has successfully accomplished multiple CTN submissions including an active support and management during the 30-day review period.

The main services that Tina provides are:
- Process management of PMDA consultations and CTN review
- Creation of timelines and agreeing with clients
- Preparing and reviewing study documents for the CTN submission
- Contacting potential study investigators for the study feasibility
- Handling regulatory inquiries during CTN review period
- Establishing operational processes and setting up a framework for working with relevant vendors
- Regulatory obligations management for conducting clinical studies
- Safety reporting process in Japan
- IP importation process including customs clearance
- Periodic CTN maintenance
- Patients referral process and communication with study monitors
- Other processes such PK kits design and preparation, and study insurance contracting.

Prior to her work at JCRO, Tina worked at a global CRO for 6 years as a CRO and Clinical Lead Support as well as global case reporting in Pharmacovigilance. As a CRA, Tina was responsible for about 65 sites, ranging from national hospitals and university hospitals to clinics.

At the global CRO, she also served as the Research Secretariat and led a successful large-scale observational study (Real-World Evidence) involving more than 33,000 patients.

Tina’s experience covers a wide spectrum of therapeutic areas including, atrial fibrillation, hyperlipidemia, diabetes mellitus type 2, sleep apnea, macular degeneration etc.

Tina has a genetic engineering major at a national university in Japan in a lab-related to malaria vaccine development.