Clinical Research Monitor (CRM)
Johns Hopkins University

Baltimore, Maryland

Posted in Education and Training


This job has expired.

Job Info




Clinical Research Monitor (CRM)
The Department of Neurology is seeking a Clinical Research Monitor (CRM) who will take the lead on compliance monitoring of predominantly large, multi-centered, clinical trials in keeping with established BIOS policies and procedures and GCP. The Clinical Research Monitor (CRM) will ensure quality, accuracy and integrity of clinical trial data throughout the full lifecycle of multiple clinical trials through utilization of a risk-based, remote monitoring approach.

Specific Duties & Responsibilities:

  • Manage site and study progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
  • Participate on risk assessments by reviewing new studies for quality assurance and general content
  • Develop standard and protocol specific forms and trial specific monitoring plans based on risk assessment
  • Ensure the collection and maintenance of required essential documents and ensure these documents are delivered to the Trial Master File
  • Assist in training new research staff regarding research compliance, including presentations sessions
  • Generate queries and conduct follow-up for non-compliance issues. Generate monitoring summary reports and communicate these findings to Investigators, Research Staff and Safety Monitoring Committee
  • Verify that written informed consent is obtained before each subject's participation in the trial. Verify that source documents, other trial records and CRFs are accurate, complete, and legible and that CRF entries reflect the source
  • Communicate deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator and take appropriate action designed to prevent recurrence of the detected deviations
  • Determine whether all adverse events (AEs) are appropriately reported within the time periods required by GCP, the protocol, the Ethic Committees (IRB/IEC), Sponsor and the applicable regulatory requirement(s)
  • Schedule compliance monitoring visits with research study staff in order to evaluate the quality and integrity of site practices to ensure GCP compliance and escalate any quality issues as appropriate
  • Assist staff in developing corrective actions for compliance review observations when appropriate
  • Help study staff to prepare for external audits. Participate in unscheduled internal reviews and compliance monitoring reviews at affiliate institutions on an as needed basis
  • Educate principal investigators, clinical sites and/or individual coordinators regarding remote monitoring and remote data entry through presentations
  • Other duties as assigned


Minimum Qualifications ( Mandatory):
  • BA/BS in medical research or scientific discipline, health care related or other appropriate discipline preferred
  • Must be eligible for certification by professional organization in the area of human subjects' research
  • Minimum 5 years of experience with clinical trials/medical research required


Preferred Qualifications:
  • Certified Clinical Research Associate (CCRA) credentialing is preferred
  • Experience with quality assurance or clinical trial auditing/monitoring, and/or good clinical practice preferred


Special Knowledge, Skills & Abilities:
  • Ability to work independently and exercise judgment necessary
  • Excellent written and interpersonal communication skills and the ability to build effective relationships both internally and with trial center staff
  • Knowledge of medical terminology and human subject research necessary
  • Strong organizational, IT and administration skills with attention to detail
  • The candidate must be proficient in Microsoft Excel and Word
  • Thorough knowledge of ICH GCP and FDA guidelines
  • Experience using Electronic Data Capturing (EDC) systems


Travel:
  • Traveling for monitoring visits expected to be minimal and in line with remote-based approach


Technical Qualifications or Specialized Certifications:
  • Certified Clinical Research Associate (CCRA) credentialing is preferred


**Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.

Classified Title: Sr. Compliance Monitoring Specialist
Working Title: Clinical Research Monitor (CRM)
Role/Level/Range: ACRP/04/MD
Starting Salary Range: $53,020 - $72,930 annually (commensurate with experience)
Employee group: Full Time
Schedule: M-F 8:30 am - 5:00 pm
Exempt Status: Exempt
Location: School of Medicine Campus
Department name: Neurology
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 HR Business Services 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.

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

To apply, visit https://jobs.jhu.edu/job/Baltimore-Clinical-Research-Monitor-(CRM)-MD-21202/823057100/





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