Associate Medical Monitor

3 weeks ago

Chicago, United States Alliance for Clinical Trial in Oncology Foundation Full time
The Alliance for Clinical Trials in Oncology Foundation (Foundation) is a foundation created to enhance and expand the ability of the Alliance for Clinical Trials in Oncology (Alliance) to conduct cancer clinical research and address important treatment questions through large-scale clinical trials. Through efforts of the Foundation in support of the Alliance, clinical trials and laboratory research are conducted to discover new or improved ways to prevent, treat, and cure many types of cancer, including leukemia and lymphoma, and cancers of the breast, prostate, lung, and gastrointestinal (GI) tract, and help educate the medical community on methods of cancer diagnosis, treatment, and prevention.

The Alliance for Clinical Trials in Oncology Foundation is looking for an Associate Medical Monitor who is excited to provide their clinical expertise and oversight for clinical trials conducted by the Alliance, from initial study design through final study close-out. We are an organization of passionate, team-oriented professionals driven to change the face of cancer.

Benefits of working at the Alliance for Clinical Trials in Oncology Foundation:
• 8 weeks of paid time off (including PTO, sick, and holidays) during year one
• Medical, Dental & Vision plans with 100% employer-paid option for employees
• Tuition reimbursement stipends
• Continuing Education
• 3% employer match for retirement investments
• Annual Employee Performance Bonus Program
• Annual Cost of Living Adjustment
• 50% commuter reimbursement
• Healthy Work/Life balance and flexibility

ROLE AND RESPONSIBILITIES

Associate Medical Monitor (AMM)

The Associate Medical Monitor (AMM) is an essential member of the Quality Management and Compliance team at the Alliance and provides clinical expertise and oversight for clinical trials conducted by the Alliance, from initial study design through final study close-out. The AMM works closely with the Study Chair (SC) and the Executive Office/Medical Monitor (EO/MM) who are clinicians responsible for medical oversight of Alliance clinical trials.

The AMM will work with assigned personnel to triage the following and escalate when necessary to the appropriate personnel:
  • Monitors clinical trials for safety compliance-related issues based on considerations such as the trial purpose, phase and complexity of the study design, clinical complexity of the study population, sample size, study objectives and end-points, the relative safety of the investigational product and prospective new drug application (NDA) registration status
  • Reviews clinical data, Key Performance Indicators (KPIs), and other centralized monitoring reports, to evaluate trends related to protocol non-compliance, ineligibility rates, adverse event rates, treatment adherence, early discontinuation, etc. for potential impact on patient safety and primary endpoint analysis. Discuss findings with the SC, EO/MM, and/or other study team members, as appropriate, to determine course of action
  • Reviews SAEs safety listings generated by Pharmacovigilance (PV) units and/or data, before submission to regulatory authorities (e.g., DSUR, IND Safety Updates) for potential trends affecting overall trial safety
  • Respond to sites' inquiries received in the pharmacovigilance mailbox
  • Reviews expedited adverse event reports, including SAEs/AESls for Alliance NCTN trials, in addition to associated external cross-reports
  • Generates a trial-specific monthly Medical Oversight Report based on key data metrics, meeting with the EO/MM at a minimum of quarterly to review and discuss findings
  • Identifies and evaluates emerging safety risks, recommends the need to correct identified deficiencies, assists in the determination of protocol modifications to remove the source of the risk, and provides recommendations for monitoring activity modification, as deemed necessary.
  • Works with the EO/MM and/SC to guide site personnel and study teams for safety and quality-related issues including if/when a subject may need to be unblinded, according to protocol unblinding plan and applicable SOPs.
  • Serves as the point of contact for sites, pharmacovigilance personnel, clinical monitors, and project teams to address safety issues (review, resolve, and document safety issues), escalating to SC or EO/MM as appropriate.
  • Assists with the identification of clinical sites that require additional training, monitoring, or both through collaborative discussions regarding safety concerns with the Clinical Study Manager (CSM), QMMC, EO/MM, or other study team members
  • Provide input and expertise to ensure Medical Dictionary for Regulatory Activities (MedDRA) consistency.
  • Reviews clinical monitoring reports submitted by 3rd party vendors and works with project managers and CRAs to ensure timely follow-up as needed and the documentation of all actions taken. Escalates clinical monitoring issues to the EO/MM and QMMC, as appropriate
  • Reviews protocol deviation (PD) listings and escalates issues to the EO/MMA; at least quarterly meets with the EO/MM to discuss a summary of important protocol deviations. Escalates critical PDs to the Quality Monitoring and Management Committee (QMMC) and oversees the process for related corrective and preventive plans (CAPA), in conjunction with quality and project teams
  • Creates and maintains timely documentation of all safety and medical monitoring issues on a per-study basis, including review and final resolution of major issues by the EO/MM and or SC. Participate in Study/Site Initiation Visits (SIV). Prepare educational materials for SIVs and other training purposes as appropriate
  • Reviews and/or develops medical oversight, and safety management plans, as applicable
  • Review clinical monitoring plans and protocol deviation plans, as applicable
  • Reports critical/serious non-compliance issues to the Alliance QMMC
  • Provide guidance relating to temperature deviations and/or product complaints for NCTN/CCP/AFT trials
  • Assure compliance with REMS/pregnancy prevention programs
  • Ensure staff coverage for time-sensitive activities
  • Other related duties as assigned to meet departmental and company objectives

Requirements

Qualifications and Education
  • 5 years or more clinical trial research experience, oncology preferred, with working knowledge of SAE reporting (documenting and reporting of events)
  • Education: RN/OCN, MSN, NP or PA, PharmD or MD
  • Knowledge of the clinical trial process and related regulations including FDA and ICH/GCP
  • Ability to work effectively in teams as well as independently
  • Ability to organize medical and scientific information to provide comprehensive support to medical oversight and other study team members as appropriate
  • Ability to manage confidential health information and data
  • Ability to manage multiple projects at a time

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