• Reporting to Clinical Operations Manager.
• Homebased position with 25% - 50% travel.
• Comprehensive salary, bonus and benefits package.

Role overview:

The Senior Clinical Research Associate (CRA) will enable AbbVie’ s emergence as a world class R&D organization, the position plays a key role in ensuring successful protocol level execution of Clinical Site Management deliverables involving start­up, execution, and close­out of studies.

Key Responsibilities:

• For assigned sites/study(s), ensure successful protocol level execution of Clinical Site Management deliverables involving start­up, execution, and close­out. Ensure site related study execution including but not limited to monitoring visits, site evaluations, site selection, and activation, and monitoring close out and visit reports. Anticipate and identify site issues that could affect timelines and develop alternative solutions.
• Ensure clinical trial management systems containing all site-specific information are maintained and kept current. Provide Local regulatory and legal requirement expertise. Ensures timely payment execution for the assigned sites/study(s) according to the clinical study agreements and as per local requirements.
• Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Stay abreast of new and/or evolving local regulations, guidelines and policies.
• Ensure audit and inspection readiness of assigned sites. Advise on pre­audit activities for GCP requirements. Prepare and follow up site audits/inspections; provide input into the CAPA preparation.
• Responsible for coaching and mentoring CRAs and providing input into their development. Responsible for mentoring CRAs for various aspects of work.
• May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager.