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Requisition ID:  117904

Clinical Research Monitor

The Department of Neurology, BIOS Clinical Trials Coordinating Center (CTCC) 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 CTCC policies and procedures and GCP. The Compliance Monitoring Specialist 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. In collaboration with clinical trial teams across the country, support of the clinical trial research goals of the BIOS Clinical Trials Coordinating Center’s (CTCC) by monitoring numerous centers’ specified trial cycle metrics, and protocol fidelity, and oversee local, institutional and federally required regulatory compliance across the network of collaborators.


Specific Duties & Responsibilities

  • Manage site and study progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.
  • Participate in 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.
  • Traveling for monitoring visits expected to be minimal and in line with remote-based approach.
  • Other duties as assigned.


Additional knowledge, skills, and abilities

  • Knowledge of medical terminology and human subject research is necessary.
  • Experience with local and/or single IRB policies and submissions.
  • Proficient in Microsoft Office Suite: Outlook, Word, Excel, PowerPoint, and Teams.
  • Proficient with SharePoint, collaborating and co-authoring of documents.
  • Experience with REDCap preferred.
  • Possess the ability to learn new software programs such as electronic data capture software, eIRB, and project management software, which will be taught on the job.


Minimum Qualifications

  • Bachelor’s Degree in related field.
  • Minimum 5 years of experience with clinical trials/medical research required.
  • Thorough knowledge of ICH GCP and FDA guidelines.
  • Experience using Electronic Data Capturing (EDC) systems.
  • Additional education may substitute for required experience and additional related experience may substitute for required education beyond HS Diploma/Graduation Equivalent, to the extent permitted by the JHU equivalency formula.


Preferred Qualifications
  • BA/BS in medical research or scientific discipline, health care, or other appropriate discipline.
  • Certified Clinical Research Associate (CCRA) credentialing.
  • Experience with quality assurance or clinical trial auditing/monitoring, and/or good clinical practice.
  • Experience with REDCap preferred.

 

 

Classified Title: Sr. Compliance Monitoring Specialist 
Job Posting Title (Working Title): Clinical Research Monitor   
Role/Level/Range: ACRP/04/MD  
Starting Salary Range: $55,800 - $97,600 Annually (Commensurate w/exp.) 
Employee group: Full Time 
Schedule: M-F 8:30 am - 5:00 pm 
FLSA Status: Exempt 
Location: Remote 
Department name: SOM Neuro BIOS 
Personnel area: School of Medicine 

 

 

Total Rewards
The referenced base salary range represents the low and high end of Johns Hopkins University’s salary range for this position. Not all candidates will be eligible for the upper end of the salary range. Exact salary will ultimately depend on multiple factors, which may include the successful candidate's geographic location, skills, work experience, market conditions, education/training and other qualifications. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/.

Education and Experience Equivalency
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines: JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for 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.

Applicants Completing Studies
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.

Background Checks
The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.

Diversity and Inclusion
The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion.

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
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf

Accommodation Information
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. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit https://accessibility.jhu.edu/.

Vaccine Requirements
Johns Hopkins University strongly encourages, but no longer requires, at least one dose of the COVID-19 vaccine. The COVID-19 vaccine does not apply to positions located in the State of Florida. We still require all faculty, staff, and students to receive the seasonal flu vaccine. 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. This change does not apply to the School of Medicine (SOM). SOM hires must be fully vaccinated with an FDA COVID-19 vaccination and provide proof of vaccination status. 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 upon 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.
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