Lowongan Kerja PPD Development (S) PTE Ltd

PPD is a leading global contract research organization, celebrating 25 years of providing discovery and development services and drug lifecycle management. With offices in 41 countries and more than 10,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe, effective therapeutics to patients and maximize returns on their R&D investments.

We seek to attract the best and the brightest talent by providing a stimulating and challenging environment. Our employees take pride in delivering innovative ideas, exceptional service and consistent quality to our clients. We understand our employees are the key to our success, and we acknowledge and reward their excellence.

Clinical Research Associate
(Malaysia)

Basic Purpose and objective:
Performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations and SOPs. Conducts site visits to assess protocol and regulatory compliance and manages required documentation Responsible for ensuring that data will pass international quality assurance audits. Represents the company in the global medical research community and develops and maintains collaborative relationships with investigational sites.

Position scope:
Serves as a primary contact with individual investigational sites that conduct clinical trials. Successful site management contributes directly to operational objectives, which in turn have an impact on project profitability. Goal is to deliver clean CRFs from an ICH GCP and SOP/WPD compliant process on time and within budget.

Duties and Responsibilities (according to relevant guidelines, laws and SOPs)
1. Identify potential investigators in collaboration with the sponsor.
2. Perform evaluation visits to assess facilities and staff so as to ensure the selection of appropriately qualified investigative sites
3. Initiate clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted
4. Perform monitoring duties as specified in the relevant procedures
5. Verify data versus source documentation and validate CRF entries
6. Generate and resolve queries as required
7. Control investigational product accountability through physical inventory and records review. Control trial supplies ordering, dispatch, return and destruction, where applicable.
8. As necessary, prepare and submit regulatory, ethics committee and provincial applications and regulatory packages
9. Ensure the proper essential documents are in place prior to trial start up and on an ongoing basis throughout the study – prepare Regulatory Compliance Review packages
10. Ensure administrative set up of sites, laboratories, storage facilities, equipment, etc
11. Organise and participate in investigator meetings as necessary
12. Provide trial status tracking and progress reports as required by the Project Manager or Clinical Team Manager
13. Administer investigator payments
14. Conduct and ensure proper trial close out and retrieval of trial materials
15. Archive relevant documents as per procedures
16. Clearly document all observations in reports and letters in a timely manner, according to accepted business writing standards. Ensure that any serious issues are immediately raised to the attention of project management, clinical team management and clinical operations management in writing
17. Maintain a working knowledge of GCP, Corporate global SOPs and applicable client SOPs
18. Facilitate effective communication between investigational sites and the PPD project team through written, oral and electronic contacts
19. Facilitate and respond to company, client and regulatory audits
20. Contribute to the project team by mentoring new members, assisting in preparation of project tools and sharing ideas and suggestions with team members.

Qualifications:
- Bachelor’s or higher graduate degree in a science related field, licensed or certified health care training or equivalent experience
- Possesses a Valid passport

Skills and knowledge:
- Knowledge and understanding of relevant regulations, e.g., ICH/GCP, FDA guidelines.
- Effective oral and written communication skills
- Excellent interpersonal skills
- Strong attention to detail
- Basic computer skills and the ability to learn appropriate software
- Good English language and grammar skills
- Basic medical/therapeutic area knowledge and medical terminology preferred
- Ability to work in a team or independently as required
- Ability to travel and spend 60 to 80% of working week at site.

Experience:
- A minimum of one to two years experience as a Clinical Research Associate / monitor or in a health sciences field / clinical research setting is required. Three years’ experience for the Senior CRA role

Interested applicants, please forward a copy of your resume, in English, to Kevin.cheng@ppdi.com.