Clinical Research Associate II

PRIMARY FUNCTION/OBJECTIVE
To enable AbbVie s emergence as a world class R&D organization the position anticipates and proactively solves study-related clinical site issues as they occur and initiates recommends and communicates corrective action ensuring successful protocol level execution of CSM deliverables involving start-up execution and close-out of studies.

CORE JOB RESPONSIBILITIES

• Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol.
• Ensures 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.

• Conducts site qualification initiation interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations Good Clinical Practices (GCPs) ICH Guidelines and AbbVie 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 regulatory inspection readiness at assigned clinical 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 by site personnel.
• Ensures safety and protection of study subjects through compliance with the study monitoring plan AbbVie 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.
• Negotiates investigator/ hospital agreements with stakeholders.
• Maintain and complete own expense reports as per local and applicable guidelines.
• Identifies evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.

Qualifications :

• Appropriate tertiary qualification in health related disciplines (Medical Scientific Nursing) preferred.
• Minimum of 2 year of clinically related experience of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. Familiar with riskbased monitoring approach onsite and offsite monitoring.
• Experience in on-site monitoring of investigational drug or device trials is required.
• Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
• 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 competing projects and deadlines.
• Ability to work understand and follow work processes within the assigned function.
• 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.

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time