Clinical Research Associate II

Advance AbbVies pipeline by striving for excellence in clinical research turning science into medicine
for our patients and leveraging new advanced capabilities to drive industry leading performance.
Partners with the investigator and site staff for meaningful and effective engagements positioning
AbbVie as the choice in clinical trials. Focus on site clinical research that ensures appropriate
conduct of the trial while driving improvement in data integrity compliance overall study performance
and customer experience.

• Considered as the primary point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials connects stakeholder to the investigative sites and strengthens AbbVies positioning.
• Aligns trains and motivates the site staff and principal investigator on the goals of the clinical trial program protocol and patient treatment principles for the trial ensuring a trusted partnership.
• Conducts site evaluation site training routine and site closure monitoring activities with compliance to the protocol and monitoring plans in accordance with applicable regulations Good Clinical Practices (GCPs) ICH Guidelines AbbVie Standard Operating Procedures (SOPs) and quality standards ensuring safety and protection of study subjects.
• Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool to report/track progress and measure impact of that strategy.
• Advanced level of competency connecting the study protocol scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. Develop solid knowledge of therapeutic area asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
• Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager.
• Responsible for continuous risk-assessment proactively and in collaboration with Central Monitoring team monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
• Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place as needed to mitigate risk and promote compliance using a customer centric approach.
• 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.
• 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 audit and regulatory inspection readiness at assigned clinical site at all times. Manages investigator payments as per executed contract obligations as applicable.

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

Experience: years
Vacancy: 1