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Clinical Research Manager IV
$102k-133k (estimate)
Full Time 8 Months Ago
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Henry M. Jackson Foundation for the Advancement of Military Medicine is Hiring a Clinical Research Manager IV Near Bethesda, MD

Join the HJF Team!
The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.
This position will be in support of Immunization Healthcare Division (IHD) of the Defense Health Agency (DHA), located at Walter Reed National Military Medical Center in Bethesda, MD. 
HJF is seeking a Clinical Research Manager IV to play a central coordinating role in the implementation of research protocols in a multi-site, multi-disciplinary clinical research network.

Responsibilities
  • Interacts regularly with clinical investigators, clinical site coordinators, regulatory and safety monitoring staff, laboratory personnel, data coordination center personnel, data analysts, biostatisticians, program managers and administrative staff.
  • Develops, implements, and oversees clinical research proposals, specifically the writing of protocols and associated documents, coordination of the proposal submission and scientific/ethical review processes, management of protocol development activities, and oversight and guidance of protocol execution activities at clinical sites. Ensures project completion and final product development.
  • Serves as the direct supervisor of clinical research site personnel and/or programmer/analysts and biostatisticians.
  • Leads the execution of analysis plans for primary and secondary study objectives.
  • Conducts literature reviews and drafts scientific and technical documents under the direction of clinical investigators and other members of the investigative team and serves as a liaison between review committees and other members of the investigative team.
  • Contributes to the development and modifications of study budgets and is responsible for budget compliance and development/tracking of protocol performance metrics.
  • Coordinates with program managers to prepare grant/funding applications, develop contracts with vendors, write progress reports for sponsors and track various aspects of the program related to research administration.
  • Reviews new concepts, protocols and sub-studies and assists in the selection of appropriate study design as well as development of preliminary analysis plans.
  • May include budgetary responsibility to include plan/forecast, prepare, approve, monitor.
  • May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role.
Required Knowledge, Skills and Abilities
  • Experience and proficiency in advanced statistical analysis.
  • Knowledge of federal and local regulations and policies pertinent to research involving human subjects.
  • Experience in the design, conduct and analysis of clinical trials and epidemiologic studies.
  • Prior experience in a clinical research environment; knowledge of biomedical sciences and clinical research.
  • Familiarity with clinical research methods, including studies utilizing randomized controlled trial, cohort, case-control, and case-series designs.
  • Knowledge and proficiency in SAS and SAS Macros (experience within a Windows environment preferred) required; knowledge of other statistical software (e.g. STATA, R) preferred.
  • Knowledge and experience with logistic regression, general linear models with repeated measures, survival analyses, and other statistical techniques for longitudinal and missing data.
  • Experience with utilization of electronic medical records preferred; background in microbiology and infectious disease epidemiology preferred.
  • Prior supervision and mentorship of study personnel preferred; ability to communicate effectively in written and oral form.
  • Ability to effectively communicate research findings in presentations and publications.
  • Prior presentation and publication record preferred; excellent verbal, written and interpersonal skills.
  • Ability to establish goals and agendas; occasional travel may be required.
  • Prior supervisory and mentoring experience preferred.
Supervisory Responsibilities
  • Direct Supervisor: Direct authority to make decisions on the following: employee hiring, disciplinary action, starting salaries and merit increases; conduct employee performance evaluations and directs work activities.
Physical Capabilities
  • Lifting: Requires lifting materials up to 10 lbs

Qualifications
Work Environment
  • This position will take place primarily in an office and clinical setting.
Education and Experience
  • Master’s Degree required in Public Health or related field. 
  • More than 10 years experience required
Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be required.
Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable. Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer. 
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Job Summary

JOB TYPE

Full Time

SALARY

$102k-133k (estimate)

POST DATE

09/20/2023

EXPIRATION DATE

05/12/2024