Job Description
GENERAL INFORMATION
§ Position: CLINICAL TRIAL ASSISTANT – PHARMACEUTICALS
§ Job code: JO-180212-146970
§ Level: Staff
§ Contract Term: Permanent
§ Recruitment Reason: New-hire
§ Expected joining date: ASAP
§ Work Location: Cau Giay District, Hanoi
§ Work Time:
- Monday-Friday (9:00~18:00)
§ Salary Range: Gross 15,000,000 VND per month
JOB DUTIES:
§ Report to Vietnamese Clinical Research Associate
§ Assigned to Clinical Research Department
§ Job Responsibilities:
- Perform non-patient related duties and provide technical/logistical support to Clinical Research Department to ensure timely and efficient initiation, management and closure of clinical trials.
- As country, clinical supplies administrator and under office head supervision to check drug room temperature weekly and handle supplies' shipment with completed documentation Support the tasks below for assigned project throughout the study:
ü Support for Trial Master File (TMF) maintenance in accordance with ICH-GCP and SOPs (SMART-KMS scanning, indexing and QC within prescribed timelines
ü Updates the trial and site information as necessary in Clinical Trial Management System (CTMS) —Trial Work in a timely manner
ü Attends appropriate training programs and project teleconferences as applicable.
ü Support ethics committee & regulatory submissions
ü Support study team to upload essential document into SMART-KMS
- Other responsibilities of the CTA:
ü Complies with the company policies, SOPs & IGs and local regulations during various projects related transactions
ü Provides back-up coverage for another CTA as necessary.
ü Supports Project Leader for production and tracking of trial metrics measurements.
ü Supports Project Leader for coordinating with sites for finalizing budget worksheets and contractual agreements.
ü Provides support as needed for drug management and finance management.
ü Maintains and ensures the availability of inventory for all non-drug supplies.
ü Provides logistic and administrative support to project teams.
ü Responsible for distribution of SUSAR/safety letters to the sites, Ethics Committee and regulatory authority, if applicable
ü Supports CRA to track study budget in country and site level as applicable.
JOB REQUIREMENTS:
§ Desirable Background & Experience:
- Qualification: Diploma or Degree in Life Science from a recognized institution
- Language Skills: Good English language skills
- Experience in Clinical Research preferred (previous study coordinator and Clinical Trial Assistant experience preferred)
- Nursing or pharmaceutical background is preferred
- Well familiar with eTMF and eCRF
- Good attitude for working under insourced CRO (Contract Research Organization)
- Strong database skills
- Highly proficient in software applications such as Word, Excel and PowerPoint
- Good written and verbal communication skills
- Ability to multitask
- Others (Preferable): Experience with health insurance and/or medical office management is considered a big plus
§ Desirable Character:
- Gender: Any
- Age: Any
- Personality: hardworking, enthusiastic, proactive