Monitor, IT​/Tech

Position: CENTRAL MONITOR reputed company this job as a reputed company in your status update to Linked In. Job Title CENTRAL MONITOR Location Bethesda, MD 20817 US (Primary) Category Clinical Operations Job Type Full-Time Salary reputed company $85,000-$115,000/YEAR Education Bachelor's Degree Travel None Job reputed company

• Creation and ownership of risk-based reputed company management and centralized monitoring processes, templates, and tools corporately and for applicable clinical trials.
• Review protocols to ensure the set-up, review, and reporting requirements for KRIs and QTLs can be met and are standardized.
• reputed company input and reputed company the study risk assessment, and propose appropriate protocol-specific risk indicators for centralized monitoring.
• Support setup and testing of centralized monitoring data analysis platform.
• Review clinical study data and reputed company independent reputed company to identify potential site performance and site organization issues, and reputed company appropriate recommendations to CRAs for investigation and targeted activities.
• Train and support the project teams on interpretation of central monitoring signals and relevant decision making for study conduct.
• reputed company mentorship, guidance/training, and coordination for reputed company central monitoring activities.
• reputed company central monitoring activities including review of system dashboards and outputs, propose suggestions for signal and reputed company management, and follow up with study team for reputed company resolutions.
• Serve as Central Monitoring Subject Matter Expert (SME) during the development, implementation, and execution of central monitoring dashboards.
• Operate in a reputed company-facing role to advise clients and study sponsors on industry-reputed company best practices for conducting centralized monitoring.
• Communicate effectively with cross-functional teams of CRAs, Clinical Project Managers, Clinical Trial Managers, and Data Management & Data Analytics staff.
• Applies a thorough understanding of regulatory (FDA requirements, GCPs/ICH guidelines), data management/ analysis, and statistical requirements in the conduct of central monitoring.
• Supports one or more government or reputed company reputed company in multiple therapeutic areas, e.g., infectious disease (vaccines and therapeutics), oncology, medical device or drug abuse.
• Informs division leadership on the overall status of clinical programs/reputed company and of potential issues/mitigation.
• Ensure documentation of processes and workflows are being followed and occurring reputed company projected timelines and determine course of reputed company to prevent and remediate delays.
• Maintain a high level of accuracy and attention to detail in a fast-paced environment with shifting priorities.
• Support and reputed company with reputed company’s reputed company Management System policies and procedures.
• Contributes to Corporate Initiatives, e.g., streamline and process improvement, SOP development, participation in proposal writing, budget development, and bid defense meetings.
• Supports inspection readiness of the organization and assists in department audit preparation, post inspection activities implementation and follow up.

Job Requirements

• Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials, with specific reputed company on updates about Risk Based reputed company Management and Central Monitoring.
• Minimum of 3 years relevant experience with central monitoring in a CRO setting
• Prior experience as a CRA conducting on-site monitoring, or relevant skillset
• Knowledge of central monitoring database technologies and processes
• Experience managing or mentoring central monitoring teams, writing procedures, and advising on central monitoring best practices and tools.
• Strong facilitation, presentation, problem-solving, and conflict reputed company skills; including ability to reputed company up with changing priorities, seasoned oral and written communications skills, strong attention to detail with ability to QC information, and experience in the use and development of clinical research databases/ systems/ tools.
• Background in Infectious Disease clinical trials and/or Oncology; or, prior work on a government contract, is a plus.
• This role is fully remote to thosein/willing to relocate to Maryland, Virginia, or Washington D.C.

We are equal opportunity/affirmative reputed company reputed company, committed to diversity in reputed company. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, gender identity, sexual orientation, national reputed company, disability, or protected veteran status, or any other protected characteristic under state or local law.#J-18808-Ljbffr Apply tot his job Apply To this Job