Experienced Clinical Research Associate SEA

Kuala Lumpur, Malaysia
Apply by 15 June 2018
Mid-level , Full-time staff position
Posted on 4 June 2018

Job Description

Purpose of the position

The Clinical Research Associate is responsible for the set-up and follow-up of clinical trials in trial sites according to applicable regulation and Good Clinical Practice, to ensure the safety of the patients participating in clinical trials, and get reliable clinical data.

Specific job responsibilities Clinical trial set-up
  • Participation in the feasibility study
  • Proposal and selection of potential Investigators, in collaboration with the Clinical Manager
  • Participation in the development of the Case Report Form and monitoring tools
  • Set up of the clinical trial in the trial sites
  • Site initiation visit management
Clinical trial monitoring
  • Periodic monitoring visits, including but not limited to check of:
  • Informed consent process,
  • Serious Adverse Event reporting by Investigators,
  • Compliance with the Clinical Trial Protocol and applicable regulations,
  • Accuracy and consistency of data in the Case Report Forms,
  • Investigational Medicinal Products and study materials,
  • Clinical Trial Documentation,
  • Motivation of Investigators, anticipation of difficulties, detection and resolution of issues
  • Communication to the Investigator of any relevant information
  • Reporting to the Clinical Manager
  • Documentation of each monitoring action (monitoring visit reports, telephone call report, email, etc)
  • Update of the trial tracking tables
  • Maintenance of the clinical trial documentation on the trial site
Tasks and responsibilities for R&D staff
  • Guarantee of the rights, safety and well-being of patients who participate in clinical trials
  • Guarantee that the reported data are accurate, complete and consistent with the source document
  • Guarantee that the clinical trial is conducted in the trial sites in compliance with the Clinical Trial Protocol and applicable regulations, and is properly documented
  • Guarantee that the trial site has adequate resources (staff, facilities…) and that the training of the Investigators and all the staff involved in the clinical trial
  • Guarantee an optimal level of communication between DNDi and Investigators
  • Manages patient recruitment strategy
  • Ensuring the tracking of the IMPs and study supplies
  • Management of the stocks of the trial sites
Job requirements Skills and attributes
  • Ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
  • Clear and systematic thinking that demonstrates good judgment and problem solving competencies
  • Very good communication skills in multicultural, multi-lingual environments
  • Ability to work effectively as part of a multicultural team
  • Well organized and structured
  • Very good analytical skills
  • Ability to contribute to the project delivery under minimum supervision
  • Ability to manage small projects if delegated by upper levels with supervision
  • Ability to supervise an Intern or Apprentice
R&D technical skills
  • Very good knowledge of Drug Discovery/Development
  • Very good knowledge of Clinical Research/Development
  • Very good knowledge of Regulatory (GCP, GLP and GMP)
  • Very good knowledge of Disease/academia knowledge
  • 1 - 3 years’ experience with graduate degree, at least one year with post graduate degree
  • 3 years of experience of Clinical Research Associate
  • Proven ability to work effectively in a team environment and matrix structure
  • Experience of working in public and private sector is highly desirable
  • Graduate or post graduate degree
Other requirements
  • Fluency in English
  • Proficiency in local languages desirable
  • Good knowledge of Microsoft Suite
Reporting line
  • S/he reports to Clinical Project Manager (function of the line manager)
  • Primary contributing manager is Clinical Trial Lead Pediatric HIV/HCV and secondary contributing manager is Head of DNDi SEA
Other information
  • Status: full time – 2 years fixed term contract

About the Organization

Drugs for Neglected Diseases initiative (DNDi) is a collaborative, patients’ needs-driven, non-profit drug research and development (R&D) organization that is developing new treatments for Neglected Diseases (www.dndi.org)

The Drugs for Neglected Diseases initiative (DNDi) was established in 2003 in Geneva, Switzerland, by six Founding partners, including the Ministry of Health Malaysia. It is a collaborative, patient-needs driven, non-profit drug research and development (R&D) organization that is developing new treatments for neglected diseases (sleeping sickness (human African trypanosomiasis), leishmaniasis, Chagas disease, mycetoma, filarial diseases, hepatitis C, and paediatric HIV) that afflict millions of the world’s poorest people. DNDi ‘s mission is to improve the quality of life and the health of people suffering from neglected diseases by using an alternative model for developing drugs and by ensuring equitable, affordable access to new and field-relevant health tools. As part of its new strategy for the period 2013-2023, DNDi adopted a “dynamic portfolio” approach enabling to address new disease areas with a revised set of operating model. In 2015, the Board of Directors decided to launch a new activity in the field of Hepatitis C (HCV) with a focused programme aiming at developing a new treatment affordable and meeting patients’ needs in South East Asia.

After 13 years of sustained growth, DNDi has built a team of approximately 200 full-time employees working across nine offices (Geneva, Rio de Janeiro, Kinshasa, Nairobi, New Delhi and Patna (India), Kuala Lumpur, New York and Tokyo).

DNDi was established in Malaysia in 2004 based in Penang, working closely with the University Sains-Malaysia. With the shift in focus of regional activities to hepatitis C, the the DNDi office was moved to Kuala Lumpur in 2016.

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