Country: United States of America
Closing date: 22 Sep 2017
Position Title: Research Assistant
Reports To: Project Manager
Location: Boston, MA. Travel up to 25% of time.
Organizational Profile
Partners In Health (PIH) is an international health organization relentlessly committed to improving the health of the poor and marginalized. PIH partners with local governments to build local capacity and works closely with impoverished communities to deliver high-quality health care, address the root causes of illness, train providers, advance research, and advocate for global policy change.
PIH currently has implementation programs in Haiti, Rwanda, Lesotho, Liberia, Malawi, Peru, Mexico, Russia, Sierra Leone and Navajo Nation. Through our partnership with Harvard Medical School and the Brigham and Women’s Hospital, we support a wide range of programs in dozens of other countries around the world.
General Responsibilities
The endTB Research Assistant, as part of a team working on a project called Expand New Drug Markets for TB (endTB), will be responsible for providing operational and outcomes research support and clinical trial support to the project team. endTB is funded by Unitaid and implemented by consortium partners PIH, Medecins Sans Frontieres (MSF) and Interactive Research and Development (IRD). The endTB project is studying the use of new TB drugs in an observational study and a clinical trial. The endTB observational study is 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. This study is ongoing in 15 countries and will enroll 2600 patients. The endTB clinical trial is a Phase III, randomized, controlled, open-label, non-inferiority, multi-country trial evaluating the efficacy and safety of five new, all-oral, shortened regimens for multidrug-resistant tuberculosis (MDR-TB).
The Research Assistant will support the research and organizational aspects of the observational and clinical studies and will work as part of a team comprising Boston-based staff and international-based site staff. This position will report to the endTB Project Manager and work closely with the endTB Study Manager andco-Leaders.
Specific Responsibilities
- Compile, catalog, and maintain study documents including standard operating procedures (SOPs), protocols, consent forms, study forms, and IRB approvals at the Central and site level.
- Coordinate with the endTB Study Manager the distribution, retrieval, and review of regulatory documents required for a clinical trial.
- Review, maintain and track documents for Central Trial Master File and site investigator files.
- Assist in training the field staff in data entry and support on-going data quality improvement.
- Interact with site staff to assist with questions related to the electronic medical record system / electronic data capture system and data entry.
- Support basic data cleaning and statistical analyses for data quality improvement, project evaluation and research.
- Understand study protocol and all forms and SOPs to ensure quality and deliverables are met across PIH sites.
- Act as the central contact for site staff and perform operational and administrative tasks to support study execution.
- Assist in the preparation of reports, abstracts, presentations, and manuscripts, including preparation of tables, graphs, citations, and copy editing.
- Support research staff with manuscript submission and editing as needed
- Assist with training materials development, editing, and translation.
- Provide research and administrative support to endTB Central staff as needed.
Qualifications
- Previous work experience in clinical and epidemiologic research setting strongly desired, preferable with exposure to data management and cleaning.
- Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
- Ability to work independently with minimal supervision.
- Excellent written and verbal communication skills.
- Ability to travel approximately 25% of the time.
- Exemplary interpersonal skills; ability to collaborate effectively with culturally diverse staff across departments and country.
- Interest in social justice strongly desirable.
- Fluency in Spanish or Russian is a plus.
- Clinical trial monitoring experience is a plus.
Partners In Health is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law.
How to apply:
Apply on our career site! Please include a Cover Letter and Resume or CV.