Experienced Clinical Research Associate SEA

Kuala Lumpur, Malaysia
[Closing date: 9 September 2018]   
                                                           

 

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)

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), Chagas disease, leishmaniasis, filarial infections, filarial diseases, mycetoma, paediatric HIV, and hepatitis C) 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 program 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.

 

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

Experience

  • 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

Education

  • 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

 

To apply

  • Please submit your application using the online form
  • Deadline for application: Accepting applications until 9 September 2018
  • Only shortlisted candidates will be contacted.