The Center for Tuberculosis Research (DOM, Division of Infectious Diseases) seeks a Program Manager to manage an Implementation Research Study in several TB high-burden countries, nested in the IMPAACT4TB consortium. The position will be based in East Baltimore but will require up to 35% international travel to project countries and elsewhere for trainings, meetings and conferences. The Program Manager will report directly to the Principal Investigator(s) and will exercise a high degree of independence in managing the study. Study management experience required.
Duties will include, but are not limited to:
Anticipates research requirements for designated patient populations
May collaborate in development and writing of protocols and consent forms, as appropriate
Collaborates in development and preparation of regulatory documents as appropriate
Applies knowledge of study design to evaluate protocol
Applies knowledge of federal and international regulations when evaluating protocol
Reviews and assesses protocol for clarity, thoroughness, logistical feasibility, maintaining subject safety etc.
Evaluates the impact on and availability of resources for study
Lists and clarifies concerns and questions about new protocols with PI and/or sponsor
Proposes and negotiates alternatives to improve protocol implementation
Collaborates in the determination of roles and responsibilities of health care team members in the implementation of study
Collaborates in the design of appropriate data collection methods
Oversees and collaborates with M&E team in development of study tools including data collection forms and eligibility checklists
Communicates with consortium coordinating partner and provides necessary documentation as appropriate
Assures compliance with local and national regulatory standards; as appropriate, prepares and submits required regulatory documents
Determines that IRB approval has been received prior to initiation of research activity
Assures that all elements of study are in place before initiation
Communicates and coordinates with sponsor, consortium partner and other stakeholders
Ensures collection of pertinent data from internal and external sources and monitors compliance with requirements of study
Records and documents protocol deviations
Prepares and submits protocol amendments and revisions as appropriate
Evaluates outcomes of study
Monitors study team compliance with required study procedures and GCP standards
Contributes to and monitors ongoing data analysis
Participates in sponsor/cooperative group/internal audits/monitoring
Assists with development and review of institutional SOPs pertaining to performance of research
Maintains records of all communication pertinent to study
Oversees reporting of study results to sponsor, consortium partners, and others as appropriate
Collaborates in manuscript preparation
May present study results at international meetings and conferences
Manages dissemination of study results to participating communities as appropriate
Requires bachelor’s degree in related discipline, and master’s degree in related discipline strongly preferred.
A minimum of five years of experience in clinical research at an academic, government, or pharmaceutical industry environment. In addition, requires experience managing complex collaborative research projects and processes.
Extensive experience with clinical research sciences, regulatory affairs.
Extensive experience with protocol and informed consent writing, data analysis, grant writing, and manuscript preparation and production.
Prior experience managing clinical research staff required.
General computer skills, with experience with Microsoft Office.
Excellent organizational skills required.
Excellent attention to detail skills required.
Knowledge of medical terminology required.
Ability to manage multiple and competing priorities
Knowledge of clinical research practices and principles required
Must have excellent time management skills
Must have excellent oral and written communication skills
Ability to work in a team and demonstrated interpersonal skills
Willingness to travel periodically to international study sites
Demonstrated ability to work successfully in international settings
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 Role/Level/Range: ACRP/04/ME 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: 60000204-SOM DOM ID TB Center 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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