Require Research Study Coordinator at Harvard University

Harvard University is devoted to excellence in teaching, learning, and research, and to developing leaders in many disciplines who make a difference globally. The University, which is based in Cambridge and Boston, Massachusetts, has an enrollment of over 20,000 degree candidates, including undergraduate, graduate, and professional students. Harvard has more than 360,000 alumni around the world.

Post : Research Study Coordinator

Duties & Responsibilities
The Department of Global Health and Social Medicine (DGHSM) at Harvard Medical School applies social science and humanities research to constantly improve the practice of medicine, the delivery of treatment, and the development of health care policies locally and worldwide. The DGHSM is at the forefront of global health. To maintain our leadership of the field, the Department must: underline our commitment to teaching and research in global health equity; maintain and enhance support for “effector arms,” with a focus on implementation and delivery; strengthen models of graduate and post-graduate training, including through global health and social medicine advanced degree programs, residencies, and fellowships; and coordinate efforts throughout Harvard to build a common agenda around global health equity.

endTB (Expand New Drugs for TB) is a multi-year project funded by UNITAID, led by Partners In Health, and with consortium partners Medecins sans Frontieres (MSF) and Interactive Research & Development (IRD). Major objectives of endTB are to study the use of new TB drugs in 2600 patients and to investigate novel treatment regimens for multidrug resistant tuberculosis. The research component of endTB includes a multi-center prospective observational study on the safety and efficacy of multidrug-resistant tuberculosis (MDR-TB) treated with multidrug regimens containing bedaquiline or delamanid and an international multicentre randomized therapeutic trial to evaluate short, oral drug regimens for the treatment of multidrug resistant tuberculosis. The trial is a collaborative project among PIH, DGHSM, MSF, the Institute of Tropical Medicine (ITM, Antwerp, Belgium) and Epicentre (Paris, France), the Institute of Research for Development (Montpelier, France). A pharmakokinetic substudy is being implemented, and a second trial is being developed by the same consortium. The study manager will work primarily on the trials and substudies and may also support the observational study.

The DGHSM is seeking an endTB study coordinator to manage clinical study activities across PIH sites, including clinical operations, pharmacy and laboratory activities, finance, data management, quality assurance, regulations, and logistics; serving as primary communication node among research sites, central team, and operational teams within partner institutions; developing and adhering to milestones; includes systems analysis and continuing improvement, documentation, and cross-site learning.

• Coordinate development and regulatory approvals of study protocol(s) and associated study documents at the central level and at PIH sites, with strict version control; coordinate changes with MSF and IRD counterparts
• Synthesize findings from data and procedure monitoring to implement corrective actions and advise central team as necessary.
• Ensure standardization of study activities and training across sites; oversee multi-center research aspects to prepare for internal and external audits, monitoring, regulatory/site visits, and inspections. Perform documentation related to these activities.
• Coach and motivate site coordination teams, facilitating the team(s)’ ability to fulfill their responsibilities in accordance with the study protocols; organize (and provide, where appropriate) site training ICH-GCP and study specifics.
• Manage design and finalization of site-specific study documents, procedures that are consistent with the protocol, ICH-GCP, and human-subjects research protection

Continuation of Duties and Responsibilities
• Ensure appropriate maintenance and storage of site investigator files and all study documents
• Support site teams in development of all study procedures (administrative, clinical, lab, logistical)
• Support site and central staff in personnel decisions and professional development
• Conduct site assessment, initiation and close-out visits on behalf of the trial manager if required
• Travel to PIH sites for research meetings, study planning, and training of site staff in study processes, including electronic data entry, quality control, and quality assurance on behalf of data manager
• Coordinate production of reports and dissemination of research (observational study)
• Represent the endTB research team at external fora, preparing or delivering presentations and articles

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Basic Qualifications
Bachelor's degree in health sciences or related field; at least 5 years of relevant research experience and research coordination experience; experience in low-resource settings outside US. Must be able to travel overseas. A Master's Degree may count towards experience.

Additional Qualifications
MPH or related degree preferred. Clinical research preferred. Thorough knowledge of ICH-GCP guidelines. Strong interest in social justice, healthcare, and global health. Excellent written, verbal communication; time management and organization; ability to prioritize and coordinate multiple tasks in timely manner.

Additional Information
Location : USA - MA - Boston
Department : Global Health and Social Medicine