Location: Waukegan, IL (hybrid preferred) or Remote

Contract Length: Through June 2027

Pay Rate: $35-38/hr

We are partnered with a global pharmaceutical company to hire an experience lead CRA to help lead an exciting clinical development initiative in the Neuro/Migraine space.

To be considered for this role, you MUST have the following experience/education:

• 3-5 years of US site management and monitoring experience (must include both non-interventational studies, onsite, and remote monitoring experience)
• Bachelors degree in science of a related field of study
• Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.

Candidates with the following experience would also be highly preferred:

• Migraine or Migraine/gepant study experience. Neuroscience and pain management experience is a secondary preference.
• Experience with site specific central IRB submissions/Advarra

Job Description:

• Monitors activities conducted by study sites as they relate to 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, and company standards
• 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 company 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, company 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.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.