We are currently seeking a Sr. Research Program Manager to direct the regulatory, implementation and logistical aspects of several research projects that relate to hepatitis C virus (HCV) and HIV infection among people who inject drugs (PWID) in India. The position will involve working with a group of principal investigators and other research staff located both in the US and India. The Sr. Research Program Manager will be primarily responsible for oversight of randomized controlled trials of behavioral interventions to improve HIV and hepatitis C treatment outcomes in India. including regulatory submissions, development and maintenance of study protocols and manual of operations, preparation of survey materials and other data collection materials, development of study training materials, working with the data management and analysis team to monitor study progress in terms of recruitment goals and outcomes, spearheading compliance considerations on international drug trials, and leading the preparation of research reports. In addition, there will at times be requests to work with other related projects with the same investigators. The Sr. Research Program Manager should be someone who works well in a collaborative atmosphere but also can maintain a high degree of independence from the PIs.
Specific Duties & Responsibilities
Manage the administrative and scientific implementation of clinical trials related to HCV and HIV treatment delivery in close collaboration with study Principal Investigators, co-investigators, collaborators and research staff located both in the US and India
Develop and maintain study protocols and manual of operations
Develop field training guides for use in India
Work with the study data manager/biostatistician to develop a study database
Monitor all study related activities including those related to study progress with respect to patient accrual, randomization, follow-up, and adverse events
Assist with grant submissions, research reports, preparation and execution of regulatory compliance documents.
Maintain regulatory compliance per DAIDS and JHU IRB
Develop and modify study data collection materials including study surveys, recruitment materials
Organize and maintain regulatory files
Perform quality assurance and quality control activities
Communicate with research teams in India to ensure compliance to the protocol and successful recruitment, follow-up and intervention delivery
Communicate regularly with the Principal Investigator, co-investigators and collaborators regarding the progress of the research and management of problems.
Take a leadership role in developing tools for tracking study progress and anticipating upcoming objectives, challenges, and solutions to present to the team.
Other duties (related research projects)
Assist with regulatory activities including IRB reporting for related studies in India as needed
Support the development of study protocols, study surveys and recruitment materials and study reports as needed
Master's degree or PhD in related discipline. 8 years related experience including significant experience in field conducting large research projects.
Desired qualifications include experience with clinical trial implementation and regulatory compliance
Special Knowledge, Skills, and Abilities
Supervisory responsibility: 2 employees, a Research Program Manager (based in India) and a Research Assistant.
Classified Title: Sr. Research Program Manager Working Title: Sr. Research Program Manager Role/Level/Range: ACRP/04/ME Starting Salary Range: $60,945 - $83,865; commensurate with experience Employee group: Full Time Schedule: Monday-Friday, 8:30am-5:00pm; 37.5 hours/week Exempt Status: Exempt Location: 05-MD:School of Public Health Department name: 10001101-Epidemiology Personnel area: School of Public Health
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