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Johns Hopkins University
Baltimore
We are seeking a **_Compliance Monitoring Specialist_** who will work under the supervision of the Sidney Kimmel Comprehensive Cancer Center (SKCCC) Clinical Research Compliance Manager. This role is responsible for conducting compliance monitoring reviews of clinical research trials in keeping with established policies and procedures of the Cancer
Job Source: Johns Hopkins UniversityJohns Hopkins University
Baltimore
We are seeking a **_Sr. Compliance Monitoring Specialist_** who will oversee the safety aspects of the clinical trial(s). Ensures the safety and integrity of the trial subjects throughout the lifecycle of the trial. **Specific Duties & Responsibilities** + Serves as the expert for all safety-related matters. + Provides coverage and consultation for
Job Source: Johns Hopkins UniversityPwC
Baltimore, MD, United States
Industry/Sector Not Applicable Specialism IFS - Risk & Quality (R&Q) Management Level Senior Manager Job Description & Summary A career in Risk Management, within Internal Firm Services, will provide you with the opportunity to advance and foster integrity based decision making and conduct by PwC professionals throughout our organisation. You
Job Source: PwCHealthCare Resolution Services
Columbia, MD, United States
JOB DESCRIPTION: Delivers remote patient monitoring and tele-health solutions for healthcare providers throughout the US. Our patient engagement software and services enable physicians to monitor and manage their patients' chronic conditions between office visits without investing in additional staff or money. By combining state of the art technol
Job Source: HealthCare Resolution ServicesHealthCare Resolution Services
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Job Description Job Description JOB DESCRIPTION: Delivers remote patient monitoring and tele-health solutions for healthcare providers throughout the US. Our patient engagement software and services enable physicians to monitor and manage their patients' chronic conditions between office visits without investing in additional staff or money. By
Job Source: HealthCare Resolution ServicesGridiron IT
Fort Meade, MD, United States
GridIron IT is seeking a Systems Monitoring Specialist local to the Ft. Meade, MD area. Security Clearance: Top Secret Clearance PRIMARY RESPONSIBILITIES: •Manage integration of the network system management tools. •Network Management Systems monitoring and reporting. •Operate as a team member on a 24 x 7 x 365 operational support team focused o
Job Source: Gridiron ITService Coordination, Inc.
Baltimore, MD, United States
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Job Source: Service Coordination, Inc.EA Engineering, Science, and Technology, Inc.
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We have an exciting full-time opportunity for an Environmental Health, Safety, and Sustainability (EHSS) Compliance Specialist to support our rapidly growing Environmental, Health, Safety and Sustainability (EHSS) consulting practice in Hunt Valley, MD. What you will do: As a Compliance Specialist, you will collaborate with an experienced team to
Job Source: EA Engineering, Science, and Technology, Inc.Baltimore, MD, United States
General Summary
We are seeking a Compliance Monitoring Specialist who will work under the supervision of the Sidney Kimmel Comprehensive Cancer Center (SKCCC) Clinical Research Compliance Manager. This role is responsible for conducting compliance monitoring reviews of clinical research trials in keeping with established policies and procedures of the Cancer Center.
Specific Duties & Responsibilities
Schedule compliance monitoring visits with research study staff. Develop protocol specific forms. Review research and medical records against clinical protocols for compliance. Prepare written summary of compliance review results. Meet with principal investigators and data support staff to review compliance results. Follow-up on results as necessary. Maintain scheduling and review information in CRMS for all protocol reviews.
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.
Schedule compliance monitoring visits with research study staff in order to monitor studies for data integrity. 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. Provide support for monitored trials in the form of research into regulations and review of protocols and Case report templates for protocol staff. Assist staff in developing corrective actions for compliance review observations when appropriate.
Assist in training new research staff regarding research compliance, including presentations at Cancer Center education sessions.
Participate on the CRC Sub-Committee by reviewing new studies for quality assurance and general content, coding new studies in CRMS.
Prepare reviews of studies by the Safety Monitoring Committee. Attend and participate in SMC monthly meetings.
Assist in the development and maintenance SOPs for the Research Manual on the CRO website as needed.
Perform periodic compliance reviews of the Oncology Investigational Drug Service pharmacy.
Other duties as assigned. This description is a general statement of required major duties and responsibilities performed on a regular and consistent basis by the incumbent(s). It should not be held to exclude other duties not mentioned
Minimum Qualifications
BA/BS required, preferably in medical research, health care related or other appropriate discipline.
Relevant experience may substitute for some education.
Must be eligible for certification by professional organization in the area of human subjects' research. Current certification preferred.
Minimum 3 years experience with clinical trials/medical research required.
Experience with quality assurance or clinical trial auditing/monitoring, and/or good clinical practice preferred.
Additional education may substitute for some experience, to the extent permitted by the JHU equivalency formula.
Classified Title: Compliance Monitoring Specialist
Role/Level/Range: ACRP/04/MC
Starting Salary Range: $47,500 - $83,300 Annually ($65,400 targeted; Commensurate with experience)
Employee group: Full Time
Schedule: M-F, 830-500
Exempt Status:Exempt
Location:Hybrid/School of Medicine Campus
Department name: SOM Onc Clinical Research Office
Personnel area: School of Medicine
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Compliance Monitoring Specialist jobs in Baltimore, MD, United States
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