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Sr. Research Program Coordinator

Employer
Johns Hopkins University
Location
Maryland, United States
Salary
Salary Not Specified
Posted Date
Jun 29, 2022

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Position Type
Administrative, Academic Affairs, Research Administration
Employment Type
Full Time
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General summary/purpose:

In collaboration with the Principal Investigators the Sr. Research Program Coordinator is responsible for the management and oversight of the following research activities: 1) Randomized trial comparing EUS-GJ and duodenal stenting for malignant gastric outlet obstruction; 2) Randomized trial comparing Z POEM vs standard septotomy; and 3) Prospective trial evaluating TIF in the management of post POEM GERD. The Sr. RPC will be will be involved in scientific discussions and coordinate the day-to-day logistical and operational tasks, have oversight of clinical research protocols, implement effective subject recruitment strategies, recruitment, screening, scheduling, testing and data management. The Sr. RPC will enroll patients, and manage the organization, entry, and maintenance and accuracy of all clinical research data for a complex and detailed clinical study.


Specific duties & responsibilities:

  • Assists with coordination between participating centers for multicenter studies
  • Assists with communication with IRB, FDA and other regulatory agencies.
  • Maintains confidential records of research trials
  • Ensures quality, consistency, and accuracy in the conduct of complex clinical research trials.
  • Prepares and maintains individual participant study binders.
  • Prepares regulatory reports and maintains all regulatory binders for enrolling trials and trials in follow-up phase.
  • Assists subjects on all activities required by protocol
  • Regularly attends research meetings and provides updates on the study progress and issues related to the research.
  • Completes accurate, concise, and legible documentation of all participant records and other source documentation and forms per protocol.
  • Collects and reviews subject evaluations/assessments, surveys, and participant interviews to develop reports for the PI and appropriate agencies and grant sponsors.
  • Verifies patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements. Confirms patient registrations and relevant data points in databases for the Clinical Research Office and other relevant Information Systems
  • Prepares and delivers presentations to subjects, faculty and consenting physicians related to research aims and goals.
  • Adheres to all protocol requirements to ensure the validity of the complex clinical research data.
  • Maintains good working knowledge of all assigned protocols and reporting requirements.


Minimum Qualifications
  • Bachelor's degree in related discipline
  • Three years related experience
  • Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula
  • Ability to travel to different locations within a 30 mile radius of the Johns Hopkins University East Baltimore campus


  • Preferred Qualifications
  • 2 years’ experience in clinical or medical research setting
  • Ability to work independently and manage multiple tasks, detail orientated, self-motivated.
  • Ability to be flexible in work conditions, hours and work well in team setting.
  • Experience in a clinical or translational research setting is required and experience in working with Federal Regulations and IRB is preferred
  • Knowledge of ethics and regulatory procedures (i.e. informed consent, IRB applications, data safety and monitoring plans) involved human subjects research; ability to work as a member of a project team.
  • Proficiency in word processing, Database, and spreadsheet software- ability to use a laptop and personal computer.
  • Possess excellent oral and written communication skills- interviewing techniques required.
  • Excellent organizational skills, strong interpersonal skills and ability to multitask.
  • Ability to function independently with high degree of motivation essential.

Classified Title: Sr. Research Program Coordinator
Role/Level/Range: ACRP/03/MB
Starting Salary Range: Commensurate with experience
Employee group: Full Time
Schedule: M-F 8:30am-5:00pm
Exempt Status: Exempt
Location: School of Medicine Campus
Department name: SOM DOM Gastroenterology
Personnel area: School of Medicine

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 Talent Acquisition Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.

Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/.

The following additional provisions may apply, depending on campus. Your recruiter will advise accordingly.

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.

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

Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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


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
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