Job Purpose
This position is responsible for project management and study site management from site selection to initiation until monitoring and close-out of assigned clinical studies in accordance with Tigermed Jyton or sponsor Standard Operating Procedures (SOPs), International Conference on Harmonization Good Clinical Practice standard (GCP)， ISO14155 and other applicable regulations.
The position is responsible for ensuring that all data generated by the assigned sites is of high quality, on time and within budget.
Responsibilities
1. Study management and site management.
* Assist IRB submission to respective IRB
* Regulatory submission if needed.
* Perform pre-study visit to ensure eligible sites are selected according to site selection criteria/protocol, including but not limited to adequate resources and experience.
* Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study initiation and conduct in compliance with protocol and relevant regulations.
* Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP and GCP.
* Track study recruitment to ensure recruitment target is achieved in all studies.
* Conduct monitoring visit according to monitoring plan and SOP; address issues with sites and complete monitoring visit report in a timely manner.
* Ensure timely coordination of study materials (medical device, IVD, drug, non-drug, equipment) to the site for start-up and throughout the study.
2. Training
* Provide ongoing training to site staff with regards to GCP, study protocol and requirements.
* Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements.
3. Documentation
* Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator site file and trial master file.
* Prepare/complete study records archiving according to protocol and sponsor requirements.
4. Safety
* Ensure safety information is disseminated to all sites according SOP and applicable regulations.
* Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations.
5. Finance and Administration
* Finalize budget and obtain signed contract from site, prior to site initiation visit.
6. Ensure Study Payment Schedule is executed and retain relevant documents/receipts.
* Study Tools and system Update and maintain Study tools/systems in a timely manner.
Minimum Qualifications
1. Academic / Major: Bachelor degree in biomedical/medical science or equivalent (e.g. medical, Nurse, Pharmacology).
2. Professional Skills
* Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/ procedures.
* Good working and proactive attitude.
* Ability to work in team.
3. Working Experience: At least 2 years of CRA experiences. Experience in at least 3 medical device clinical trials.
4. Language ability: Good written and oral English.
5. Computer: Proficient Microsoft Word, Excel, PPT and Outlook, etc
6. Other abilities such as Communication skills\Information-gathering skills Knowledge and/or experience in medical practice is a plus.