Lead Clinical Research Associate

Country:	Thailand
City:	Bangkok
Req ID:	4274
Description
FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. Our staff includes experts in Health, Education, Nutrition, Environment, Economic Development, Civil Society, Gender, youth, Research and Technology-creating a unique mix of capabilities to address today’s interrelated development challenges. FHI 360 serves more than 60 countries and all 50 U.S. states and all US/ territories. We seek qualified candidates for  Lead Clinical Research Associate, in Bangkok, Thailand Lead Clinical Research Associate Job Description: Supervises mentors and assists other FHI 360 staff to perform their clinical monitoring duties correctly.  Leads the clinical monitoring work of assigned studies.  Works with other FHI 360 staff at assigned study sites to oversee and assist with site compliance issues relating to the conduct of study protocols.  Leads systems to monitor and reports study progress, compliance and deliverables. MAJOR DUTIES AND RESPONSIBILITIES: Work closely with other research staff to conduct clinical research activities (e.g. site training, protocol development, study-specific procedure development, project management, study implementation, data analysis, data monitoring, data management, clinical monitoring, paper/report writing) Work with implementing agencies (IAs) and study sites to develop subagreements or other contractual documents to implement research studies. Prepare and track site budgets and study spend Monitor the qualitative and quantitative progress of research and research implementation activities Oversee the collection of pharmacovigilance data by study sites and ensure that it is complete and reported correctly and within the required timeline. Participate in selecting, developing and building capacity of country project sites Assist with the set-up, preparation for and conduct of regulatory meetings, and professional meetings as needed Review or supervise other FHI 360 staff to review study documents for completeness and accuracy, including informed consent forms, study CRF’s, site regulatory documents, study logs and other study documentation/  Perform source data verification as required by study protocol and monitoring plan Prepare and provide trainings to study sites and investigational teams on the study protocol, study specific procedures, Good Clinical Practice (GCP) and research ethics Provide technical assistance to site staff as needed Supervise FHI 360 CRAs performing mentoring, co-monitoring visits and provide training as well as their performance on an ongoing basis Ensure compliance of assigned studies with GCP’s applicable regulatory requirements, FHI 360 policies and Standard Operating Procedure (SOPs), Global Research and Services work instructions KNOWLEDGE, SKILLS AND ABILITIES : Knowledge of and experience with Good Clinical Practices (GCP) and its application to clinical research. Knowledge of clinical and/or public health research methodology as related to research implementation and conduct, data collection instruments, data collection and analysis. Ability to work well in a team. Ability to supervise projects, set priorities and plan for the successful implementation of clinical research studies and programs. Well-developed written and verbal communication skills in both Thai and English. Knowledge of and ability to use electronic data processing systems to gather, store, retrieve and analyze data. Sensitivity to cultural differences and understanding of the political and ethical issues surrounding clinical research. Ability to travel both in-country and internationally as necessary to monitor projects, and provide Technical Assistance and training when needed. Travel may be up to 35% of time. MINIMUM QUALIFICATIONS: BS in pharmaceutical, medical sciences or related field with experience in clinical research, preferably in infectious diseases. Minimum of 5 years of on-site clinical monitoring experience. Good command of written, spoken Thai and English; Good organizational skills. Knowledge of and experience with Good Clinical Practices and its application to clinical research Ability to travel domestically and internationally up to 35% of time. Interested candidates may register online through FHI 360’s Career Center at http://www.fhi360.org/careers . Please submit CV/resume and cover letter including salary requirements. Please specify source in your application.  National local applicants only will be considered.