广州招聘

Position Description:
The Senior Clinical Research Associate (SCRA) is responsible for monitoring and managing the conduct of clinical projects according to ICH-GCP, Standard Operating Procedures (SOP) and applicable Study Specific Procedures (SSP) and local egulatory requirements. In addition to the responsibilities as a CRA, the SCRA provides mentoring and coaching for junior personnel, and supports department training programs as a trainer and/or a topic expert.

Responsibilities:
1 Contribute comments/input in the development of Protocol, Informed Consent Form (ICF), Case Report Forms (CRF) and other project related documents.
2 Evaluate potential sites and provide recommendations for selection of qualified sites.
3 Develop country/site specific ICF according to the core study ICF.
4 Prepare the package for institutional review boards (IRB) and local regulatory authority submissions and obtain IRB/regulatory approvals for conducting the clinical trial.
5 Perform and/or assist junior CRAs in site budget estimation and prepare/manage the clinical trial agreements with investigators/sites.
6 Design project specific work sheets, tools, forms, logs and templates.
7 Track, manage and control the site budget and expenses within approved budget and in line with the project milestones as requested.
8 Manage/coordinate the investigational products and clinical trial materials for the sites in compliance with regulatory requirements.
9 Monitor and report the project status at the sites in a timely manner.
10 Key contact person for the communication between sites and study team.
11 Prepare, arrange and conduct the training of site personnel.
12 Conduct site initiation, monitoring and site close-out visits in compliance with monitoring plan, ICH-GCP, SOPs, local regulations and other applicable project-specific plans.
13 Prepare monitoring report according to the SOP.
14 Assist the investigator for auditing/inspection of project.
15 Coordinate with the sites to ensure all adverse events and follow-up are appropriately reported and reconciled according to regulations.
16 Identify, analyze and resolve the issues at the investigator sites.
17 Assist in project quality management by accompanying junior CRAs during monitoring visits based on the requirements defined in the project specific plan.
18 May sever as the project manager on potential project assigned by line manger.
19 Take on additional responsibilities that may be assigned by line manager.

Qualifications:
1 A 4-year BS (Bachelor of Science) degree or equivalence experience. dvanced degree is a plus.
2 3 years experience in clinical research environment.
3 2 years experience in on-site monitoring and proven records in clinical study execution and GCP.
4 Good command of written and spoken english.
5 Good organization and communication skills.
6 Ability to manage multiple tasks.
7 Good command of written and spoken english or other second language.
8 Good organizational and communication skills.

PPC is one of the prestigious CRO grew up in Taiwan with local affiliates around the Asia-Pacific region in Japan, China, Hong Kong, Singapore and Australia for Asian Study. The company mission is to continuously dedicate to serving the pharmaceutical and biotechnology industry with cost-effective, safe and high standard quality for clinical and non-clinical drug development and shortening the lead time to market.

“One Company, World-Class Solution” is more than a mission but our commitment to the serving clients hat keeps us motivated to continually improve in all aspects and exceed our limits.