- Group:Clinical Research Management and Governance, OUCRU Indonesia
- Hours of Work:1.0 FTE
- Tenure:Initially for01yearswithpossibilityof extension
- Reporting to: Site Clinical Operations Manager (with dotted line to Clinical Trial Pharmacist)
Background
The Oxford University Clinical Research Unit (OUCRU) is a large-scale clinical and public health research unit, with sites offices in Ho Chi Minh City and Hanoi in Vietnam, Jakarta in Indonesia and Kathmandu in Nepal. In Vietnam, we are hosted by the Hospital of Tropical Diseases (HTD) in Ho Chi Minh City, and the National Hospital for Tropical Diseases (NHTD) in Hanoi.OUCRU Nepal closely collaborates with the National Academy of Medical Sciences in Kathmandu, and OUCRU Indonesia exists in partnership with the Universitas Indonesia. As aWellcomeTrust Africa AsiaProgramme, we have received considerable support from theWellcomeTrust since our establishment in 1991.
OUCRU’s vision is to havelocal,regionaland global impact on health by leading a locally driven researchprogrammeon infectious diseases in Southeast Asia. Priority is given to health issues important to the hospitals where we work, and to the countriesas a whole whereweoperate: Vietnam,Indonesiaand Nepal. All work is intended not only tobenefitthe patients seen daily at our host hospitals, but also to help improve patient care.
- Medical doctor with demonstrable experience of at least 1-year duration in one or more of the job descriptions outlined above;
- BLS and ACLS Certification arerequired;
- Previousresearch experience is preferred;
- Excellent written English and Bahasa Indonesia, with proven ability to research and write accessible;
- Computer literacy andproficiency;
- Excellent interpersonal skills;
- Demonstratea high leveloforganizationskills and attention to details. Ability to manage and/or supervise complex research endeavors;
- Ability to work effectively as a team with healthcare personnel at all levels;
- Evidence of self-motivation, initiative,creativityand attention to detail;
- Demonstratehigh levelof organization skills and attention to details;
- Ability toobserve, comprehend,analyzeand solve problems independently;
- Recognize scope of decision making, with ability to receive directions asappropriate;
- Having prior experience in malaria research is a definite advantage;
- Willing to belocatedat trial site withinrequiredcontract period.
Key Responsibilities
- Organiseclinical research activities at site and supervise studyteam* (study physicians, health workers,nurse, *)asapplicable) daily clinical research related activities.
- Carry out clinical activities as scheduled in the protocol, including but not limited toobtainsInformed Consents, performs physical examination, checks vital signs and symptoms, performs ECG examination, and draws blood sampling for laboratory test.
- Conduct screening on the potential participants, based on inclusion and exclusion criteriastatedin the protocol.
- Manages participants’ visit or delivery as scheduled, at the clinic or out ofclinic.
- When needed, visits study participants at their house or workplacein a timely mannertomonitortheir health or to do any follow-uprequiredas required by the protocol.
- Report and discuss with clinical safety responsible, Principal Investigator or relevant PICimmediatelyin case of SAE occurs among participants
- Provide primary healthcare management or first aid to study participants experiencing AE/SAE related to the study intervention
- Arrange the transport/evacuation of study participants with SAE and any case of medical emergency occurrence, to the referral hospital. – Report and discuss all progress of clinical work of research activities to the principal investigator wheneverrequired
- Document and report any protocol deviation occurred during the study periodin a timely manner.
- Ensure clinical research activities at site are conductedin accordance withthe latest version of clinical research protocol, Good Clinical Practice (GCP), Cara Uji Klinik yang Baik (CUKB) and other applicable local regulations and requirements