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Sr. Research Program Coordinator

Employer
Johns Hopkins University
Location
Maryland, United States
Salary
Salary Not Specified
Date posted
Sep 21, 2020

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General Summary/Purpose

The Center for Immunization Research is seeking a Senior Research Program Coordinator to assist in the clinical operations of vaccine trials and work closely with the study coordinators and Principal Investigators. The position requires someone with significant background clinical knowledge who can serve as an ambassador and educator in the community to inform potential participants about upcoming vaccine studies and answer questions. The ideal candidate in this position will be bilingual, have previous community-based research experience, able to thrive in relatively uncertain environments, tolerate ambiguity, be willing to innovate, problem solve and to embrace and overcome the development challenges and complexity associated with vaccine clinical trials. This individual must be able to flex to different positions within the team. This individual is responsible for being compliant with the Center’s procedures, FDA regulations, GCP, ICH requirements and any other applicable regulations.

Specific Duties & Responsibilities

  • Coordinates moderate to complex vaccine, treatment and challenge trials in accordance with ICH-GCP, under the Direction of the Principal Investigator.
  • Ensures regulatory compliance in conduct of protocol(s).
  • Liaison between research team and faculty, PI, laboratory, Pharmacy, collaborators, IRB, FDA, and Sponsor.
  • Oversees day-to-day activities of support staff on study and train new staff as required.
  • Develops consent form(s) for clinical trials from protocol(s).
  • Prepares materials for IRB.
  • Conducts literature searches to provide background information. Abstracts and index information based on knowledge of subject matter. Gathers information for and contributes data to complex reports as required by Principal Investigator and/or Sponsor. Contributes to source document development. Maintains site study binder for all assigned studies.
  • Facilitates subject screening, recruitment, interviews, eligibility, consenting activities.
  • Coordinates the scheduling of volunteer study appointments and follow-up visits/phone calls to ensure protocol compliance. Documents protocol deviations.
  • Calculates and requests subject payments.
  • Monitors compliance with quality assurance and the quality control goals of vaccine trial. Meets with study monitors and assists with monitoring visits. Monitors the clinical course of subjects enrolled in assigned research protocols.
  • Manages data and ensures that study subject electronic case report form information is collected, reviewed and accurately entered into databases any other subject data tracking system as designated by the Principal Investigator and/or Sponsor.
  • Performs query resolution.
  • Interacts regularly with other members of the research team regarding protocol development and implementation. Recommend changes to protocol operations based on results and goals.
  • In compliance with assigned protocol, ensures the proper collection/recording/documentation of vital signs and laboratory specimens; this may include venipuncture, urine collection, and nasal secretion collection, stool collection.
  • Processes, stores, and ships specimens according to protocol and regulatory guidelines. Communicates with internal laboratory vendors (i.e., JHH Core Lab), outsourced laboratory vendors (i.e., Quest Diagnostics), and study sponsors regarding on-site clinical laboratory needs, management of specimens, shipping/transportation of specimens.
  • Operates clinical laboratory machinery and maintains laboratory equipment.
  • Performs and documents clinical laboratory tests in compliance with CLIA guidelines (i.e., urine HCG), and performs research laboratory tests as assigned by the Principal Investigator.
  • Contributes to CIR and study-specific Standard Operating Procedures (SOP), and Guidelines as assigned by the Principal Investigator.
  • Able to flex schedule to some degree to accommodate inpatient study demands. Must be willing to work both within the established CIR setting and also community outreach sites.

Minimum Qualifications(Required)

Bachelor's degree in related discipline.

  • Three (3) years related experience.

Additional education may substitute for required experience, to the extent permitted by the* JHU Equivalency Formula:18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for the 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. *

Preferred Qualifications

  • Bachelor’s degree in a health-related science.
  • Medical experience.
  • Fluency in Spanish or other language.
  • Previous experience in community-based research.

Special Knowledge, Skills, and Abilities

  • Good organizational skills.
  • Good interpersonal skills.
  • Familiarity with basic medical terminology.
  • Ability to work within a team and to work independently with moderate direction and limited supervision.

Maintains current Human Subjects, CPR certification, IOTA training, Biohazard material training and any CIR required in-services.

  • Must be certified via SOCRA or ACRP or willing to become certified within two years of hire/promotion.
  • Must be certified in CPR and maintain current certification during employment.
  • Ability to stand, walk or sit for an extended period of time.

Classified Title: Sr. Research Program Coordinator
Working Title: Sr. Research Program Coordinator ​​​​​
Role/Level/Range: ACRP/03/MB
Starting Salary Range:$38,920 - $53,520/ commensurate with experience
Employee group: Full Time
Schedule:Monday - Friday,8:00a - 5:00p / 37.5 hrs per week
Exempt Status: Exempt
Location:05-MD:School of Public Health
Department name: 10001144-Ctr for Immnztn Rsch Vaccine Scis CIR
Personnel area: 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://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.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

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