Others Jobs Clinical Research Associate Fsp- Thailand Position at PPD Development (HK) Limited
- Job vacancies posted on: 7 months ago
As a competent company, we PPD Development (HK) Limited are looking for candidates for the position of clinical research associate fsp- thailand with full time work system. We are looking for candidates who uphold honesty and discipline at work, with minimum criteria , experienced in and domiciled in Others and surrounding areas.
Our company offers competitive salary that can be adjusted to how skilled the capability of interested candidates will be, with monthly base salary ฿24,000 - ฿45,000 in accordance with the decisions of our company's HRD.
|Company||PPD Development (HK) Limited|
|Position||Clinical Research Associate Fsp- Thailand|
|Work Experience||1 year|
|Type of Work||Full Time|
|Minimum Salary||THB 24.000|
|Maximum Salary||THB 45.000|
Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follow-up on findings as applicable.
Participates in investigator meetings as necessary. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
Provides trial status tracking and progress update reports to the team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System).
Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections.
Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner.
Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members.
Contributes to other project work and initiatives for process improvement, as required.
|Address||P P D Development (HK) Ltd., Flat 802-04, 8/F, 625 King's Road, North Point, HK, Hong Kong|
- Onsite Monitoring
- Monitors investigator sites
- Ensures data accuracy
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PPD is a leading globalcontract research organizationproviding
comprehensive, integrateddrug development,laboratoryand lifecycle management services. Our clients and partners includepharmaceutical,biotechnology,medical
device, academic andgovernmentorganizations. With offices in 47 countries and approximately 20,00 professionals worldwide, PPD applies innovative technologies, therapeutic expertise
and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health.
- Industry: Medical/Pharmaceutical