Clinical Research Development

1.Writing bioequivalence study or clinical trial protocols.

• Writing drug information, pharmacology, physiology, study

methods including study design, selection of subject, drug administration, blood sampling and subject safety monitoring.

• Writing volunteers’ information sheet and informed consent

form.

1. Writing bioequivalence or clinical trial report.

• Collect data from other department such as validation and bio-

analysis data and statistical analyses to generate the report.

• Writing in results and conclusion.
• Design source document and case report form (CRF).

3.Writing clinical report

1. Submit protocol to EC and follow up protocols until approved.
2. Amend protocol to EC and follow up protocol until approved.
3. Prepare data logger for transportation investigational product or

standard substance including print out data for keeping in its trial master files.

1. Complete investigational product and standard substance

accountability log book and forms including import, export, dispensing and dosing.

1. Attendance pharmacy facility which is humidity chamber, refrigerator,

air conditioner and any pharmacy territories including record temperature, humidity, print out for keeping its files.

1. Project presentation before starting clinical period to inform the product and project detail information to relevant staffs.
2. Inform consent, subject eligibility process (beverage, tobacco, food and medicine consumption behavior) and compliance check.
3. Writing and revise SOP which relevant to clinical research

development.

1. Support other department information

*Must have a valid pharmacy license

Qualifications: Male or female Good command of both Thai and English Thai citizen only New graduated or 0-1 year of experience in Pharmacy or research field Good computer skill Education Bachelor's degree or higher in Pharmacy* Must have a valid pharmacy license* Knowledge of ICH-GCP would be advantage