TREAT Asia-Therapeutics, Research, Education, and AIDS Training in Asia-is a network of clinics, hospitals, research institutions and community organizations working to ensure the safe and effective delivery of HIV/AIDS treatments throughout Asia and the Pacific. TREAT Asia is searching for the following to be based in Bangkok, Thailand.Clinical Research Associate (Full-time)
The Clinical Research Associate (CRA) is based in TREAT Asia’s Bangkok office. The CRA assures the implementation of clinical research study planning and procedures, as assigned. The position works in collaboration with co-investigators and study staff at candidate and participating clinical sites, associated laboratories, technical experts, and other partners to conduct study initiation and monitoring activities in compliance with the protocol, international clinical practice standards, and all applicable local laws and regulations, Foundation policies, and additional quality assurance standards. The CRA performs management of study site activities to ensure the collection of accurate clinical data within given timelines and carries out individual responsibilities while working in a team environment.
DUTIES AND RESPONSIBILITIES INCLUDE AND ARE NOT LIMITED TO:
• Works with research team members to set project goals, identify potential strategies for achieving goals, prioritize and allocate resources, schedule project activities, and adhere to activity time lines and budgets.
• Manages all aspects of the assigned clinical study(ies) at all assigned clinical sites to ensure patient safety, adherence to appropriate safety regulations and data integrity.
• Monitors the clinical study(ies), which includes the review of case report forms (CRFs) and source documentation to ensure adherence to study protocol(s) and consistency and scientific validity of the data.
• Provides necessary support, including technical and scientific guidance, to clinical site personnel to ensure consistency in interpretation and exchange of scientific information as part of the clinical study(ies).
• Develops study-specific monitoring tools and other related documents, as needed.
• Manages the query resolution process between clinical sites and the respective data management center.
• Prepares for and conducts on-site qualification assessments, study initiation procedures, interim monitoring, and close-out monitoring visits at clinical sites.
• Maintains/reviews regulatory documents as required.
• Tracks recruitment and enrollment rates, receipt and review of completed CRFs and grant documentation to ensure the efficient execution of the clinical study(ies), as required.
• Involved in the preparation of documentation for submission to institutional review boards and/or ethics committees and other relevant regulatory authorities, as well as coordination of submissions with appropriate clinical site staff and /or the Project Manager.
• Prepares visit reports and assists with preparation of progress and financial reports to donors, as required.
• Organizes and attends project-related investigators’ meetings, teleconference calls, and trainings. This includes event preparation, logistic coordination, communications, and preparation of meeting summaries.
• Coordinates communications between clinical sites by phone, video conference, and on-site visits.
• Assists the Project Manager and Lead Investigators, as required.
• Performs other job-related duties that may be assigned.
Requires a BA/BS degree in a science and/or health care field, nursing degree, or equivalent combined training; plus moderate clinical or related research experience with independent field monitoring experience. Experience working in HIV/AIDS clinical research desired, including knowledge of HPV and HIV/HPV care and treatment issues.
A minimum of three (3) years clinical research experience as a monitor in the pharmaceutical or biotechnology field or clinical research organization OR two (2) years as a research study monitor plus a minimum of two (2) years direct clinical research experience as a coordinator (e.g., study, data, compliance) OR two (2) years as a monitor plus a minimum of two (2) years of experience in HIV/HPV activities.
Outstanding written and verbal communication skills, as well as public speaking ability. Good written and spoken English language skills. Excellent interpersonal and organizational skills.
National and regional travel required, up to 50%.
Email your CV to Human Resources Department: firstname.lastname@example.org
by 25 MAY 2012.
Only short-listed candidates will be contacted.
Treat Asia (amfAR)
Exchange Tower, 21th Floor, Suite 2104, 388 Sukumvit Road,
Klongtoey, Bangkok 10110
Telephone (66) 0-2663-7561 Fax (66) 0-2663-7562