Senior Clinical Research Associate

Job Description:

Great opportunity to work as a CRA III / Senior Clinical Research Associate at a leading CRO
 
JOB TITLE
Senior Clinical Research Associate / SCRA / CRA III
 
LOCATION
Kuala Lumpur / Malaysia (Office-based, however, flexiblity to work some days at home)
 
BENEFITS
Competitive salary and benefits package on offer for the right candidate
Continuous training and support provided
Ongoing career development opportunities
Flexible working environment
Chance to work at a highly recognised CRO with global offices all over the APAC Region
 
ROLE
Plan, prepare and arrange follow-up routine monitoring and close out visits in accordance with the relevant study plan
Complies with, and adheres to local rules and regulations, Code of Federal Regulations (CFR) / International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor SOPs.
Management of site location and performance of junior CRAs (CRA I)
Be actively involved in motivating and guiding investigators and site staff to ensure obligations in regards to study timelines
Refers to contractual requirements when performing source data verifications
Timely completion and submission of Case Report Forms in accordance with the Clinical Monitoring Plan/Data Management Plan
 
EXPERIENCE/QUALIFICATIONS REQUIRED
BA/BS in Science/Health Care field, or Nursing degree, or a combination of education and experience equivalent to.
Clinical research experience (4 year+), as well as advanced independent field monitoring experience.
Knowledge of SOPs, FDA, WI, and other local regulations, additionally, an understanding of ICH GCP guidelines.
Appropriate level of understanding and application of relevant standards for therapeutic areas and indications.
Bilingual in both Malaysian and English to a business proficiency level
 
ABOUT i-PHARM consulting
 
i-Pharm Consulting is a leading global Pharmaceutical Recruitment Company. We service our clients across the APAC region from offices in Singapore and Sydney. We always have a wide range of positions available in Malaysia. If this role is not suitable, Shirley Kim is also available to discuss other possible positions or answer any general questions regarding your career and the current market.
 
TO APPLY
If you would like to discuss this vacancy further, please call Talent Acquisition Specialist for the APAC market, Shirley Kim on +65 (0) 3163 3100, or email skim@i-pharmconsulting.com.