The Center for Tuberculosis Research (DOM, Division of Infectious Diseases) is currently seeking a Program Manager to monitor the regulatory, implementation, and data collection aspects of a Research Study in Ethiopia and South Africa. This study is funded by Unitaid. The goal of this project is to increase the uptake of short course preventive therapy for tuberculosis (TB) among child household contacts of people diagnosed with TB. The study will compare the effectiveness of community-based child contact investigation to that of facility- based child contact investigation. This Baltimore-based position will involve working with a group of principal investigators and other research staff located in the US, Ethiopia and South Africa. Specifically, Aurum Institute in South Africa and KNCV in Ethiopia. These partners are responsible for overall implementation of the study in their respective countries and will work closely with the JHU team on data collection and monitoring. There will at times be requests to work with other related projects with the same investigators. The Program Manager should be someone who works well in a collaborative atmosphere, but can also maintain a high degree of independence. This position will require about 35% international travel.
Specific duties and responsibilities:
Develop and maintain study protocols and manual of operations.
Assess the protocol for clarity, thoroughness, logistical feasibility, and maintenance of participant safety.
Propose and negotiate alternatives to improve protocol implementation.
Communicate with research teams in Ethiopia and South Africa to ensure compliance to the protocol and successful recruitment, follow-up and delivery of intervention.
Monitor all study related activities including those related to study progress with respect to participant accrual and follow-up.
Perform quality assurance and quality control activities.
Monitor study team compliance with GCP standards.
Knowledge of federal and international Ethics and GCP requirements; monitor regulatory compliance in each country.
Manage IRB submissions to JHU IRB.
Assist with development and review of SOPs as relevant.
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 anticipating upcoming objectives, challenges, and solutions to present to the team.
Preparation of data collection materials; collaboration with the data management and analysis team to monitor study progress in terms of recruitment goals and outcomes.
Collaborate with the study data manager/biostatistician to develop a study database.
Ensure collection of pertinent data and monitor compliance with study protocol.
Preparation of research reports.
Oversee reporting of study results to sponsor, consortium partners, and others as appropriate.
Collaborate in manuscript preparation.
May present study results at international meetings and conferences.
Bachelor's degree in related discipline; Master's degree strongly preferred.
Pediatric clinical experience helpful.
A minimum of five years of experience in clinical research and regulatory compliance in developing countries; demonstrated ability to work successfully in these settings.
Ability to travel internationally.
Demonstration of cultural sensitivity.
Excellent organizational skills.
Excellent attention to detail.
Ability to manage multiple and competing priorities
Must have excellent oral and written communication skills
Ability to work in a team with demonstrated effective interpersonal skills
General computer skills, with experience with Microsoft Office
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job .
Classified Title: Program Manager
Working Title: Program Manager
Starting Salary Range: $60,945-83,865
Employee group: Full Time
Schedule: M-F 8:30-5
Exempt Status: Exempt
Location: 04-MD:School of Medicine Campus
Department name: 10002813-SOM DOM Infectious Disease
Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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