Research Program Manager

Location
Maryland, United States
Salary
Salary Not Specified
Posted
Nov 23, 2020
Employment Type
Full Time

General Summary/Purpose:

The Department of Epidemiology is seeking a full-time Research Program Manager that will serve as a member of a coordinating center team that oversees the management of study operations, data and quality control for large, multi-center clinical trials conducted by a network of 15 clinics across the United States. The trials are funded by the American Lung Association, NIH, and pharmaceutical/device manufacturers.

The Research Program Manager will manage activities at the Data Coordinating Center (DCC) for American Lung Association Airways Clinical Research Centers (ALA ACRC) for the studies conducted by the network. Studies include MATCH, a clinical trial of an intervention for asthma, a study on COVID-19 in patients with COPD (LEEP-COVID), and a large cohort study on lung health (Lung Health Cohort). The manager will work directly with the study principal investigators. The manager will coordinate and manage administrative and scientific implementation of the MATCH trial as well as participate in the conduct of the LEEP-COVID study and LHC. The MATCH trial and the LHC study are also collecting data on COVID-19 exposures and beliefs as COVID-19 has a direct impact on lung health. The MATCH trial is a clinical trial that evaluates Medication Therapy Management (MTM) video tele-healthcare intervention to address poor adherence to asthma medications in adolescents and young adults with asthma. The overall hypothesis is that MTM provided during private video encounters plus electronic adherence self-management (EAM), using Propeller medication use sensors, improves ICS adherence and prolongs the time to first asthma exacerbation event requiring systemic corticosteroid treatment compared with electronic adherence self-management alone. The entire study will be conducted virtually, no in-person visits are required. The manager will work with the principal investigator at Nemours Children Center and DCC investigators to manage study implementation and conduct; and work independently to modify study documents as needed. The manager will serve as the primary liaison to the single IRB for the study and will work with clinical centers to obtain and maintain IRB approval for the trial. The manager will monitor activities at clinical centers to ensure that protocol and data collection procedures are adhered to; identify protocol deviations; and advise clinical center personnel on reporting, and provide corrective training. The manager will communicate orally and through written materials with clinical center directors and personnel, study sponsors, and regulatory bodies.

Specific Duties/Responsibilities:

  • Train and monitors clinical site activities.
  • Manage quality assurance programs for MATCH.
  • Manage and monitor distribution of equipment for the trial (mobile spirometers, medication sensors).
  • Help to trouble shoot virtual procedures, e.g., spirometry, visit, diary cards for MATCH and LHC.
  • Monitor the implementation of the intervention with pharmacists at University of Florida.
  • Work with ALA to develop promotional materials for the trial.
  • Update study project officer at NIH and ALA sponsors regarding current status of the trial.
  • Maintain single IRB for the project; work with clinical sites to ensure that all regulatory reporting requirements are met for the trial, e.g., adverse events and IRB submissions.
  • Answer protocol-related questions from clinic staff about all 3 studies.
  • Run basic (non-statistical) reports on study data for all 3 studies.
  • Create materials and reports for meetings and publications. Attend study meetings and prepare meeting minutes.
  • Work with data analyst to integrate databases from intervention, biweekly electronic diary cards, mobile spirometry, medication sensors and data collected at study visits.
  • Use principles of project management to organize project workload and meet deadlines.
  • Manage the monitoring of data quality and regulatory compliance.
  • Manage certification of clinical center staff for study procedures.
  • Organize and work with study analysts to generate data status reports and clinic performance reports for funding agencies and IRBs.
  • Special projects will be assigned by principal investigators.
  • Serve on protocol committee for MATCH Trial.
  • Serve on writing committees responsible for preparing manuscripts detailing study results.
  • Make study investigators at the DCC aware of problems or potential problems; work with investigators to find solutions.
  • Perform tasks for LEEP-COVID and LHC as assigned.
  • Help to integrate MATCH activities into other ALA-ACRC projects, including LHC and LEEP-COVID.
  • Performs other duties as assigned.
Minimum Qualifications:

  • Bachelor’s Degree in related field experience required.
  • Five (5) years related experience required.
  • Demonstrated supervisory or lead responsibilities required.
  • Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.

JHU Equivalency Formula:18 graduate degree credits (semester hours) may substitute for one year of experience.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.

Preferred Qualifications:

  • Master’s degree in public health or a related field preferred.

Special Knowledge, Skills, and Abilities:

  • Experience with single IRB program for multicenter studies.
  • Familiarity with asthma studies and respiratory research procedures, e.g., spirometry.
  • Ability to work with limited supervision, make decisions and establish work priorities on procedure- oriented operations.
  • Able to perform duties of sensitive or confidential nature.
  • Must be detail-oriented.
  • Excellent communication (verbal and written), organizational and interpersonal skills are essential.
  • Final applicant for this position may be required to complete skills assessments appropriate to position description.
  • Must have proficiency in Microsoft applications for production of documents, spreadsheets, tables, and slides.
  • Must have excellent writing and editing skills, strong organizational skills, and ability to work independently and collaboratively.
  • Must have proficiency with REDCap database management.

Classified title: Research Program Manager

Working title: Research Program Manager

Role/Level/Range: ACRP 37.5/E/04/MD

Starting Salary Range: $52,495 - $72,210 (commensurate with experience)

Employee group: Fulltime

Employee Status: Exempt

Schedule: Monday-Friday –8:30am-5:00pm 37.5hrs/Wk - This position will be remote until normal campus activities resume

Location:415 N Washington St., Baltimore MD

Department name: 10001101-Epidemiology

Personnel area (School): BSPH – Bloomberg School of Public Health

The successful candidate(s) for this position will be subject to a pre-employment background check.

If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office atjhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.

The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.

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.

Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until filled.

EEO is the Law
Learn more:
https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.pdf

School of Public Health - East Baltimore Campus


The successful candidate(s) for this position will be subject to a pre-employment background check.

If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.

The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.

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.

Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until filled.

EEO is the Law
Learn more:
https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
Important legal information
http://hrnt.jhu.edu/legal.cfm

Similar jobs

Similar jobs