Clinical Research Associate

• 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 14 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 followup 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 :

• Minimum of 1 year of clinicallyrelated experience of which a period of 6 months is preferable in clinical research monitoring.
• Experience in onsite monitoring of investigational drug or device trials is required. 
• Oncology experience is preferred.
• Must be willing to travel to sites to conduct onsite monitoring.
• Current indepth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
• Current indepth 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.
• Bachelors degree is required. 

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our shortterm incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion.  It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.

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