Clinical Research Monitor Jobs

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.
• Provide recommendations and guidance to study specific operations teams and assist in audit readiness and preparation.
• In consultation with PM and QMC, develop and implement effective corrective and preventive action plans for all quality issues identified at assigned sites.
• The Clinical Research Monitor will be responsible for monitoring activities across multiple protocols.
• 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.
• Coordinate upcoming and ongoing monitoring assignments while meeting expected timelines for completion of monitoring activities and submission of written monitoring reports.
• Builds positive relationships with principal investigators and site personnel.
• Manage on-site medication accountability and inventory throughout clinical study.
• Perform remote and on-site monitoring & oversight activities in accordance with protocol, GCP/ICH Guidelines, and AFT SOPs.
• Ensure compliance with regulations, guidelines, and policies for studies implemented at sites.
• In conjunction with the AFT IHCRA, manage and maintain information and documentation in CTMS and eTMF.
• 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.
• 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.
• In conjunction with the AFT IHCRA, collect, review, and monitor required regulatory documentation for study maintenance and study close-out.
• Verify that trial data entered in the EDC is consistent with patient clinical notes and other source documentation (SDV).
• Adhere to the protocols' Clinical Monitoring Plan, e.g. monitoring visit type, frequency, and required critical monitoring activities.

Requirements

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

Benefits

• 100% Medical Option, Dental & Vision for employee, with 50% spouse and children - begins on the 1st day of employment
• 20 Days PTO, 5 Sick Days & 10 Holidays Off (Already Designated)
• Tuition Reimbursement
• Annual Employee Bonus Program
• Annual Cost of Living Increase
• 50% Transit or Parking paid
• Match 3% of a Simple IRA.