Research Coordinator

The Research Coordinator will work full-time on an NIH-funded study that will enroll drug-resistant tuberculosis (TB) patients at a study site located in East London, South Africa. Patients will be screened by local, South African study staff within 2 weeks of the patient initiating a TB treatment regimen containing linezolid. After consent, participants will be randomized 1:1 to either receive standard of care treatment, or therapeutic dose monitoring. Participants will complete up to 8 study visits over 6 months of TB treatment; during these visits, clinical data will be collected through interviews and from medical record abstraction, and blood and sputum specimens will be collected for study-related testing. The Research Coordinator will establish a hybrid work schedule with the PI, working in the Einstein DGIM office at least 2-3 days per week when not traveling. The Research Coordinator will also visit the South African study site 3-4 times per year during 1-2 week trips.

Responsibilities:

• Provide principal administrative and research support to the Principal Investigators (PI) in the administration and implementation of an NIH funded, pragmatic open-label randomized control trial conducted at a site in South Africa.

• Manage the day-to-day operations of the project with US- and South Africa-based investigators, data managers, study coordinator and clinical staff.
• Work with Principal Investigators (PI) to develop and update study protocols, including the data collection tools/case report forms (CRFs).

• Develop and maintain standard operating procedures (SOPs) for study activities.
• Develop and monitor implementation of project work plans.
• Track screening, enrollment and follow-up data collection of study participants; prepare regular reports for the PIs about participant recruitment and completion of study visits.

• Train and support South African study coordinator, research nurses and research assistants to ensure compliance to all aspects of the project protocols and national and international regulations.
• Prepare agendas for and coordinate project meetings and phone calls. Write and distribute minutes from all meetings.
• Partner with Einstein REDCap team to develop and maintain study database and securely store study data.
• Oversee data collection by South African research staff, perform quality control of CRFs and REDCap data entries, and troubleshoot challenges that emerge.
• Update study specimen tracking information in OpenSpecimen.

• Conduct quarterly site monitoring at the South African recruitment site. When international travel is not possible, quality control of study documentation will be conducted from the U.S. through review of scanned and emailed documents.

• Assist in drafting data reports, preparing conference abstracts, and presentations related to the project.

• Prepare and submit ethics applications, including amendments and annual renewals to the Einstein Institutional Review Board (IRB); oversee ethics applications at all relevant site IRBs.
• Work closely with Principal Investigator and other senior research team members to create and submit applications to regulatory bodies in U.S. and South Africa, including but not limited to the U.S. clinicaltrials.gov, South African Health Products Regulatory Authority (SAHPRA) and South African National Clinical Trials Register (SANCTR).

• Assist the PIs in the management of the study budget, tracking of subcontract invoices from collaborating institutions.
• Prepare annual report to NIH, summarizing study progress – including successes and challenges - and outlining goals for future.
• Other duties as assigned.

Experience and Educational Background:

• Bachelor’s Degree in public health, clinical epidemiology or related field and 3-5 years of experience required. Master's Degree preferred.
• At least two years of experience collecting data for human subjects research (e.g. conducting interviews, collecting biologic specimens, extracting medical records). Experience working on clinical trials is preferred.
• Interest in working on international research projects is preferred.

Skills and Competencies

• As part of a team, must be able to manage multiple tasks and priorities, work independently with minimal supervision, and adhere to study protocol.
• Advanced working knowledge of Microsoft Word, Excel, and PowerPoint.
• Familiarity with database and statistical software (e.g., REDCap and SAS, Stata or R).
• Excellent interpersonal, organizational, and communication skills; detail oriented.
• Able to write scientific documents.
• Able and willing to travel internationally multiple times per year to study sites during 2 week trips, to support the needs of the project.