START Study Coordinator

The Institute of Human Virology, Nigeria (IHVN) seeks to hire a research oriented medical professional as a coordinator of the Strategic Timing of AntiRetroviral Treatment (START) study. The International Network for Strategic Initiatives in Global HIV Trials(INSIGHT)currently coordinates the START study. START is an international randomized trial to determine whether starting antiretroviral therapy (ART) early (before CD4 drops to less than 500 cells/mm³), rather than waiting until CD4 drops to less than 350 cells/mm³ (when evidence from randomized trials supports starting ART), reduces the occurrence of serious morbidity and mortality. After successfully completing its initial phase in which over 1000 participants were enrolled from 22 countries in the Americas, Europe, Africa, the Middle East, and Australasia, START has expanded into 36 countries and plans to enroll a total of 4000 participants in 237 sites by December 2012. The entire study is expected to take about 6 years, with follow-up ending in December 2015.In Nigeria, the START study sites are National Hospital, Abuja and the University of Abuja Teaching Hospital, Gwagwalada. This study is being funded primarily by the National Institute of Allergy and Infectious Diseases (NIAID), U.S. National Institutes of Health (NIH), through a grant to the University of Minnesota, which is the lead institution in the INSIGHTgroup. The University of Minnesota is the sponsor of this study. This study is also being conducted with additional funding from the AgenceNationale de Recherchessur le SIDA et les HépatitesVirales (ANRS, France); BundesministeriumfürBildung und Forschung (BMBF, Germany); the Australian National Health and Medical Research Council (NHMRC), the Department of Bioethics at The Clinical Center at NIH, NEAT - European AIDS Treatment Network; National Heart, Lung, and Blood Institute; National Institute of Mental Health (NIMH); National Institute of Neurological Disorders and Stroke (NINDS); and the Division of Clinical Research (NIAID). Additional support is being provided by Abbott Laboratories, Inc.; Bristol-Myers Squibb; Gilead Sciences, Inc.; GlaxoSmithKline, Inc.; Merck & Co., Inc, and Tibotec Pharmaceuticals, Ltd.

POSITION PURPOSE

The START Study Coordinator will coordinate and administer research study associated activities in addition to assisting with project planning, and ensuring that pre-established work scope, study protocol, and regulatory requirements are followed. He/She will help with recruitment and coordination of research subjects, as appropriate, and serve as principal administrative liaison between IHVN and the study site(s). The Study Coordinator will also oversee and coordinate the provision of administrative and staff services to the Investigator of Record (IoR) and otherinvestigators; develop and maintain recordkeeping systems and procedures.

DUTIES AND RESPONSIBILITIES

The Study Coordinator is responsible for the daily activities of the study and will act in the following capacity:

1. Reading and understanding all the information in the study documents, the informed consent, and the protocol.
2. Screening, consenting and enrolling eligible participants.
3. Plans and coordinates the initiation of research study protocol, and the establishment of operating policies and procedures.
4. Plans, implements, and maintains data collection systems in support of research protocol; may coordinate the collection and analysis of research data for use by local investigators.
5. Recruits, instructs, and coordinates research subjects as appropriate to specific study objectives and work scope.
6. Ensures the smooth and efficient day-to-day operation of research and data collection activities; acts as the primary administrative point of contact for IHVN and study site(s) and as the principle operational liaison for other research organizations, funding agencies and regulating bodies. 7. Supervises and coordinates the provision of support services to investigators and researchers.
8. Monitors the progress of research activities; develops and maintains records of research activities, and prepares periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory bodies.
9. To implement quality control process throughout the conduct of the trial.
10. Ensures organization and transport of participants' samples for testing as described in study protocol.
11. Takes action on protocol deviations and violations, reports such deviations and violations to Site Investigator and IoR
12. Reviews quality control and ensures quality assurance: reviews informed consent, monitors follow-up home visits to ensure result feedback, spot-checks screening forms to ensure participant eligibility, checks CRFs for accuracy and adherence to good clinical practice and periodically queries data to ensure accuracy and completeness.
13. To participate in clinical floor activities on an ongoing basis with research staff to ensure adequate clinical support for trial activities.
14. Send weekly monitoring reports to the IoR and study team.
15. Ensure smooth and timely completion of study activities by staff and assists with study activities when necessary.
16. Ensures proper documentation of study items.
17. Liaises and communicates with IoR and site investigator especially on evolving problems and challenges in a timely manner.
18. Ensures timely and direct reporting of adverse events to investigators.
19. Performs other duties as needed to ensure optimal conduct of study at site.

EDUCATION AND QUALIFICATIONS:

1. A medical degree (MBBS)

2. Masters in Public Health (MPH) or Masters of Science (MSc) degreein health-related discipline is preferable

3. Two or more years of clinical research experience

4. Excellent leadership, organizational, and communication skills in English

5. Strong management capacity to work independently and effectively prioritize projects and tasks

6. Ability to maintain confidentiality and assist with situations that may require discretion

7. Demonstrated understanding of the complexity of issues relating to HIV/AIDS

8. Experience with management of HIV infection especially in the area of provision of antiretroviral therapy (ART)

9. Knowledge of statistical software

Specific Technical Competence Requirements

1. Understanding of ICH/GCP guidelines for human research

2. Understanding of Code of Federal Regulations for Human Subjects

3. Computer competency including proficiency in Microsoft Word and Excel

4. Spirometry, phlebotomy skills, and any other technical skills related to the completion of a study visit as required by the protocol.