Clinical Research Monitor

The Clinical Research Monitor will work under the Executive Director of Clinical Trial Operations and the Associate Director of Clinical Trial Operations to oversee activity at Alliance for Clinical Trials in Oncology sites participating in Alliance Foundation Trials (AFT) clinical trials. This position is responsible for completing clinical monitoring activities at participating sites. This includes Source Data Validation (SDV) of clinical study data entered on the Case Report Forms (CRF) in the Electronic Data Capture (EDC) system, review and reconciliation of the Investigational Site File (ISF) with the Electronic Trial Master File (eTMF), ensure proper documentation of Investigational Product (IP), and ensure overall adherence to protocol procedures. The Clinical Research Monitor works in partnership with the AFT Project Manager and individual study teams to complete all site monitoring activities across assigned AFT projects and ensures all participating sites are compliant with Good Clinical Practice (GCP), SOPs, policies, and regulatory requirements throughout the life of assigned clinical trials.

Role and Responsibilities

• In conjunction with the Project Manager (PM) and Quality Management and Compliance (QMC) team, develop the scope of work for clinical monitoring and/or monitoring services, and associated study plans, e.g., clinical monitoring plan.
• Adhere to the protocols' Clinical Monitoring Plan, e.g. monitoring visit type, frequency, and required critical monitoring activities.
• Monitor clinical trial progress, in conjunction with the AFT In-House Clinical Research Associate (IHCRA), through a combination of remote data review and remote/on-site monitoring visits.
• Verify that trial data entered in the EDC is consistent with patient clinical notes and other source documentation (SDV).
• Coordinate upcoming and ongoing monitoring assignments while meeting expected timelines for completion of monitoring activities and submission of written monitoring reports.
• Perform remote and on-site monitoring & oversight activities in accordance with protocol, GCP/ICH Guidelines, and AFT SOPs.
• In conjunction with the AFT IHCRA, collect, review, and monitor required regulatory documentation for study maintenance and study close-out.
• Manage on-site medication accountability and inventory throughout clinical study.
• In conjunction with the AFT IHCRA, manage and maintain information and documentation in CTMS and eTMF.
• Confirm the collection of laboratory samples as specified in the protocol and the resulting lab data when central or correlative laboratories are used.
• Support the study specific operations team with communicating with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.
• In consultation with PM and QMC, develop and implement effective corrective and preventive action plans for all quality issues identified at assigned sites.
• Provide recommendations and guidance to study specific operations teams and assist in audit readiness and preparation.
• Ensure compliance with regulations, guidelines, and policies for studies implemented at sites.
• Builds positive relationships with principal investigators and site personnel.
• Actively participate with study team to stay current with study needs, communicating as needed with sites within defined timelines. Participate in regular operations team group meetings.
• The Clinical Research Monitor will be responsible for monitoring activities across multiple protocols.

Requirements

• A minimum of a BA/BS degree is required
• Degree in a health or science major preferred
• Minimum two years clinical monitoring experience required, with a strong preference for oncology monitoring experience
• Solid understanding of the drug development process, including Good Clinical Practice (GCP) and FDA Code of Federal Regulations
• Deep knowledge of monitoring procedures and entire clinical trial process
• Excellent organizational, leadership, and problem-solving skills
• Excellent written and verbal communication skills
• Solid computer skills
• Ability to successfully work both within a team and independently
• Ability to travel to sites when needed for on-site monitoring
• Fully COVID-19 Vaccinated

Benefits

• 100% Medical Option, Dental & Vision for employee, with 50% spouse and children - begins on the 1st day of employment
• 20 Days PTO, 10 Sick Days & 10 Holidays Off (Already Designated)
• Tuition Reimbursement
• Match 3% of a Simple IRA.
• 50% Transit or Parking paid
• Annual Employee Bonus Program
• Annual Cost of Living Increase