Research Study Monitor Consultant
Location:	Kenya
Job Code:	706
# of openings:	1
Description
RESEARCH STUDY MONITOR CONSULTANT VACANCY TITLE:  Research Study Monitor Consultant PROGRAM: Shang Ring Project REPORTS TO: Medical Associate EngenderHealth is a leading global women’s health organization committed to ensuring that every pregnancy is planned, every child is wanted, and every mother has the best chance at survival. In 20 countries around the world, we train health care professionals and partner with governments and communities to make high-quality family planning and sexual and reproductive health services available— today and for generations to come. Background Three randomized controlled trials have demonstrated that Male Circumcision has partial protective effect of up to 60% against heterosexual acquisition of HIV. In order to achieve the intended public health impact, as many uncircumcised men need to be circumcised within the shortest time possible. The current conventional techniques take long and in a set up where human resource is already stretched to the limit, this can prove burdensome. EngenderHealth in collaboration with Cornell University and Kenya’s Ministry of Health have undertaken several phases of a study on the Shang Ring, a male circumcision device, in Homa Bay County Hospital, Homa Bay County. Funded by the Bill & Melinda Gates Foundation, EngenderHealth seeks to carry out a two phase study that shall enroll clients seeking medical male circumcision aged 10 years and above. The study shall be conducted in two sites, Vipingo Health Centre (Kilifi) and Homa Bay County Hospital (Homa Bay). EngenderHealth is seeking to hire a Study Monitor reporting to the Medical Associate for the study. The Study Monitor will be responsible for providing assessments and routine monitoring of data quality at each site in Kilifi and Homa Bay Counties. Terms of Reference 1. Gain a concise understanding of the study protocol and related SOPs. 2. Monitor 2 study sites located in 2 counties in Kenya to assess compliance with protocol, sponsor, Good Clinical Practice and regulatory requirements in order to ensure the safety of participants and accuracy of data 3. Conducts pre-study, site initiation, interim monitoring, and study closeout visits and completes associated reporting requirements in accordance with EngenderHealth SOPs, including making arrangements with sites to ensure needed personnel will be available during the monitoring visits. 4. Ensure the compliance of regulatory documents at both sites as complete and up to date. 5. Inspection of storage, dispensing and inventory tools of study related items. 6. At interim monitoring visits verifies informed consent and reviews electronic case report forms (eCRFs) and other source documents for completeness and accuracy, including comparing data to information on source documents, identifying problems/questions with data on CRFs and working with study site staff to resolve identified issues to the greatest extent possible. 7. Ensures follow-up of site issues and action items identified during site visits, including resolution of problems related to data collection and reporting 8. Provides timely and accurate reports to Medical Associate, Principal Investigator    Qualifications • Proficient in all appropriate regulations and guidelines related to clinical monitoring, including local regulations pertaining to randomized controlled trials. • Completion of relevant workshops or continuing education, including clinical monitoring training, Good Clinical Practice, Research Ethics, Regulatory Standards. • Completion of supervised field training in monitoring of clinical research study sites and previous experience monitoring clinical research study sites. • Familiarity with electronic data collection desirable. • Ability to discuss sexual behavior and HIV risk with men and women • Comfortable working in a health care facility or clinical environment • Ability to work independently without direct supervision • Excellent planning and organizational skills • Good written and verbal skills in English and Kiswahili • Significant experience as a clinical monitor • Ability to travel to both sites Duration of Assignment Up to 30 days over a 10 month period Consultant Fee The consultant fee will be based on previous experience. To apply: Please visit www.engenderhealth.org   to submit your applications not later than 27th October 2014