InClinica is a global, clinical contract research organization (CRO) with experience in multiple disease states, drug targets, and device technologies, conducted across all stages of clinical trials.
InClinica specializes in leading companies through all stages of the clinical trial process. Our experience in drug and device development and access to world-class experts, who are critical to trial design and execution, lead to a better anticipation of common and not-so-common mistakes, oversights and assumptions that can derail a study.
InClinica serves all phases of clinical development, with particular strength assisting small to mid-sized companies who are entering first-in-human and phase 2 studies or who need to generate data related to 510k clearance, a de novo 510k application, or a PMA.
Sr. CRA (Clinical Research Associate) position in Kuala Lumpur, Malaysia responsible for supporting regional site management and monitoring activities for assigned clinical trials.
Day to day:
- Participate in the implementation of assigned trials in accordance with ICH-GCP, organizational SOPs, industry regulation and local guidelines.
- Regional site management and monitoring. (site qualification assessment, site selection, monitoring visits, budget and contract negotiation, initiation, monitoring and close-out visits, plus maintaining appropriate regulatory documentation
- Site staff training.
- Data Management for all site monitoring activities.
- Assist in QC review of the study.
- Collaborating and communicating with a variety of internal and external customers
- Travel is up to 50% within Malaysia.
- BS/BA or equivalent required, preferably with a healthcare or life science degree.
- 5 years of regional site monitoring experience is required.
- CPR experience is preferred.
- Experience working with the Drug Information Association (DIA) Reference Model of TMF management preferred.
- Documented experience working with the ICH-GCP, formal training preferred.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice
InClinica is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. All your information will be kept confidential according to EEO guidelines.