Provide principal administrative and research support to the Principal Investigator (PI) in the administration and implementation of an NIH funded project being conducted at multiple sites 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 Investigator (PI) to develop and update study protocols, including the data collection tools/case report forms (CRFs).
Develop and maintain standard operating procedures (SOPs) for activities at each study site.
Develop and monitor implementation of project work plans.
Track screening, enrollment and follow-up data collection of study participants; prepare regular reports for the PI about participant recruitment and study-visit completion.
Train and supervise 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 databases and securely store study data.
Oversee data collection by South African research staff and troubleshoot challenges that emerge.
Conduct quarterly site monitoring at the international study site(s). When international travel is not possible, quality control of CRFs 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.
Assist the PI in the management of the study budget, tracking of subcontract invoices from collaborating institutions.
Other duties as assigned.
Experience and Educational Background:
Bachelor’s Degree in public health, clinical epidemiology or related field and 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 with 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 or Stata).
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 2-3 week trips, to support the needs of the project.