Clinical Coordinator
The University of North Carolina research team has been conducting research building capacity in northern Vietnam 15 years. We have been conducting a number of randomized control trials (RCTs). The UNC team has expertise with both behavioral and clinical research and has studied a variety of infectious diseases and comorbid conditions in men and women from general and key populations. The UNC-VN was also chosen to conduct HPTN 083, a clinical trial to evaluate the safety and efficacy of the injectable agent, cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW). This is a double blind, two-arm randomized trial and will be implemented in 5 years. We are now seeking a talented, dedicated and committed individual to join our team in Vietnam to conduct a new and exciting research study. This study is conducted in a cooperation with the National Hospital for Tropical Diseases with study site for participant recruitments based in Yen Hoa Health Clinic of Cau Giay Health District Center.
Position: 01 Clinical Coordinator
Based in Hanoi.
Report to: The UNC Project Director in Vietnam
Position Summary:
The incumbent of this position will coordinate daily clinical activities in the HPTN 083 study site, including but not limited to the following:
Duties & Responsibilities:
- Develop SOPs for Participant examination and Participant Schedule;
- Review and report adverse events as requested by the sponsor;
- Obtain medical histories and conduct physical examinations, including assessment of symptoms, of all screened and enrolled study participants in accordance with research study protocol requirements;
- Complete study-related case report forms and source documentation as per protocol guidelines;
- Review all screening laboratory results to determine participant's study eligibility;
- Review all study visit laboratory results, reported symptoms and other adverse events to determine the relatedness to the study drug;
- Write and sign study specific prescription and corresponding HPTN 083 prescription for the study drug used; write other prescriptions, e.g., for oral contraceptives, for study participants as needed;
- In collaboration with other Site staff and the HPTN Network Statistical Data Management Center, participate in quality assurance activities including peer review of case report forms, source documentation, informed consent forms for completeness and accuracy, and respond to data queries from the network statistical and data management center.
- Maintain accurate, comprehensive study records and source documentation.
- Conduct all research activities in accordance with study protocol, standard operating procedures and other appropriate institutional regulations, procedures, and policies, including procedures to safeguard confidentiality of study participants.
- Attend study specific and study related trainings and meetings as requested by the site's Principal Investigator.
- Perform other duties as assigned.
Required qualification and skills:
- University degree for Medical Doctor
- Fluent in both spoken and written English;
- Preferred Qualifications - Experience in clinical research studies involving human subjects, preferably with HIV/AIDS trials.
- Ability to work independently and be self-motivated;
- Excellent organizational, interpersonal and communication skills.
- Be able to take weekend call on a rotating schedule, usually by telephone, when needed.
- Advanced in Microsoft Office (Word, Excel, Access, PowerPoint).
Salaries and Benefits: Competitive salary
How to Apply:
Interested candidates are invited to send a cover letter with contacts of three references and a CV to Ms. Le Thi Thuc Anh at [email protected] (in the subject line, please put “UNC Clinical Coordinator”) or by post to the office No.6, Lane 76, Linh Lang street, Ba Dinh, Ha Noi no later than 15 August 2016
We are sorry that only short-listed candidates will be contacted for interview.