Regional Study Coordinator / Monitor

Program: Fistula Care

Reports To: Study Manager, RCT Manager

EngenderHealth works to improve the health and well-being of people in the poorest communities of the world. We do this by sharing our expertise in sexual and reproductive health and transforming the quality of health care.

We promote gender equity, advocate for sound practices and policies, and inspire people to assert their rights to better, healthier lives. Working in partnership with local organizations, we adapt our work in response to local needs.

It is routine practice for women to have an indwelling bladder catheter after fistula repair surgery, however scientific evidence on the optimal duration of catheterization is limited.

Fistula Care, a project of EngenderHealth, in collaboration with the World Health Organization (WHO) and the US Agency for International Development (USAID) is about to embark on a randomized controlled trial (RCT) to examine whether short-term (7 day) catheterization is either equivalent to, or no worse than, longer-term (14 day) catheterization in terms of successful fistula closure.

Shorter-term catheterization would have important implications for service delivery: it would reduce hospital stays for women, free bed space at facilities, reduce costs, allow for a greater number of patients to receive clinical care, and potentially reduce the probability of healthcare-associated infections following surgery.

Job Summary

EngenderHealth is dedicated to improving the health and well-being of people in hard-to-reach communities in the world. EngenderHealth is seeking to hire a Study Coordinator/Monitor reporting to the Study Manager for the RCT.

There are two positions available; one to work with study sites primarily in French-speaking countries and another to work with study sites in English-speaking countries. These positions include both coordination of activities at 4-5 study sites located in 4 countries and also routine monitoring of data quality at the same sites. One position will be based in Guinea and the other in Kenya.

Responsibilities Include:

• Coordinates study activities at 4-5 study sites located in 4 countries to ensure smooth implementation of the study, including facilitation of effective communication between study sites and WHO/Geneva and EngenderHealth/New York.
• Monitors 4-5 study sites located in 4 countries to assess compliance with protocol, sponsor, Good Clinical Practice and regulatory requirements in order to ensure the safety of participants and accuracy of data
• Supervises a Research Assistant based at each of the 4-5 study sites.
• Conducts pre-study, site initiation, interim monitoring, and study closeout visits and completes associated reporting requirements in accordance with EngenderHealth and WHO SOPs, including making arrangements with sites to ensure needed personnel will be available during the monitoring visits
• At interim monitoring visits verifies informed consent and reviews case report forms (CRFs) 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.
• Retrieves completed CRFs from study sites and sends them to WHO/Geneva for data entry
• Ensures follow-up of site issues and action items identified during site visits, including resolution of problems related to data collection and reporting
• Works with sites to resolve queries generated by WHO/Geneva during data entry and cleaning
• Provides timely and accurate reports to RCT Study Monitor
• Performs other tasks involved in conducting the clinical research study as assigned.

Knowledge Skills and Experience:

• 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.
• Successful completion of Research Ethics Training Course in last 6 months
• Previous experience supervising others.
• Ability to discuss reproductive and sexual health behavior with women
• Ability to work independently without direct supervision
• Excellent planning and organizational skills
• Flexible and willing to adapt to new work demands
• Excellent written and verbal communication skills in English. The West Africa position requires fluency in both French and English.
• Post secondary degree in science in health care field, e.g., nursing, clinical officer or other post secondary degree with significant experience as a clinical monitor.
• Willingness to travel 30-50% time.

To Apply

Please visit the careers page at www.engenderhealth.org to view the full job description as well as submit you details online by 28 July 2011. Please include details of your salary history and salary requirements.

EngenderHealth complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities.