Job Description:
Responsibilities:

• Monitors activities conducted by study sites as they relate to Client non-interventional studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Client Standard
• Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Provides timely, and complete monitoring reports including actions items and follow-up.
• Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Client Standard Operating Procedures (SOPs) and business processes.
• Overviews the overall activities of site personnel over whom there is no direct authority and motivates / influences them to meet study objectives. Proactively manages the site and ensures action plans are put into place as needed to ensure compliance. Ensures audit readiness at assigned sites.
• Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events, if applicable, by site personnel.
• Ensures safety and protection of study subjects through compliance with the study monitoring plan, Client SOPs, ICH Guidelines, and applicable regulations.
• Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
• Manages investigator payments as per executed contract obligations.
• Manages site specific central IRB submissions and approval, including tracking
• Maintenance of site files with in the TMF.
• Manages site specific updates to CTMS systems
• Site feasibility: at the direction of the study management team, evaluates and recommends new/potential investigators/sites on an on-going basis. to assist in the placement of planned study with qualified investigators/sites.

Qualifications:

• Bachelor's degree in science or relevant field of study
• 5 years of site Management and Monitoring experience, which includes a period of 2-3 years of non-interventional trial and remote/logic check monitoring experience. Note: both on-site and remote monitoring experience is required.
• Experience with Migraine or Migraine/gepant trials preferred. Neuroscience and pain management experience is a secondary preference.
• Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
• Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with deadlines.
• Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity.
• Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated.
• Ability to use functional expertise and exercise good judgment.
• Demonstrated business ethics and integrity.

Job Types: Full-time, Contract

Pay: $43.06 per hour

Expected hours: 40.00 per week

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to Relocate:

• North Chicago, IL 60064: Relocate before starting work (Required)

Work Location: In person