Clinical Research Associate II

Key responsibilities:

• Anticipates and proactively solves study-related clinical site issues as they occur and initiates recommends and communicates corrective action to ensure successful protocol-level execution of Clinical Operations deliverables involving start-up execution and close-out of studies.
• 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 quality standards in conducting clinical research.
• Conducts site qualification initiation interim monitoring and study closeout visits for Phase 14 studies in accordance with applicable regulations Good Clinical Practices (GCPs) ICH Guidelines AbbVie SOPs and business processes.
• Oversees 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. Maintains and completes own expense reports as per local and applicable guidelines.
• Identifies evaluates and recommends new/potential investigators/sites on an ongoing 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 1 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.
• Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
• Advanced knowledge on existing and emerging local regulatory and legal requirements ICH/GCP Guidelines and applicable policies.
• Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.
• Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
•  Advanced ability to leverage technology tools and resources to provide customer centric support based on the health of the site.
• Strong interpersonal skills with excellent written verbal active listening and presentation skills with ability to establish and leverage site relationships and trusted partnerships through engagement motivation and training.
• Ability to use functional expertise with appropriate guidance leverage critical thinking  skills and apply good judgement to address clinical site issues.
• Acts with integrity in accordance with AbbVie code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.

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 :

Yes

Employment Type :

Full-time