Allergan Aesthetics, an AbbVie company, is hiring a Clinical Research Associate II to advance AbbVie's pipeline by striving for excellence in clinical research. You will turn science into medicine for patients and leverage new capabilities to drive industry-leading performance. Your focus will be on site clinical research to ensure appropriate trial conduct while driving improvement in data integrity, compliance, overall study performance, and customer experience.
What You'll Do
- Serve as the primary point of contact for the investigative site, providing contextual information on clinical trials and strengthening AbbVie’s positioning.
- Align, train, and motivate site staff and principal investigator on the goals of the clinical trial program, protocol, and patient treatment principles.
- Conduct site evaluation, site training, routine, and site closure monitoring activities in compliance with protocol, monitoring plans, regulations, GCPs, ICH Guidelines, and AbbVie SOPs.
- Develop and customize site engagement strategy for assigned studies, gathering local insights and utilizing CRM tools to track progress and measure impact.
- Connect study protocol and scientific principles to day-to-day clinical trial execution, evaluating and ensuring effective recruitment and retention techniques.
- Mentor and train less experienced CRAs and may participate in global/local task forces and initiatives.
- Perform continuous risk-assessment and monitor activities conducted by clinical sites to detect early performance or patient safety issues.
- Resolve site risk signals and ensure preventative and corrective action plans are put into place to mitigate risk and promote compliance.
- Identify, evaluate, and recommend new/potential investigators/sites on an ongoing basis to assist in study placement.
- Ensure quality and timely submission of data from study sites, including appropriate reporting and follow-up for all safety events. Ensure audit and regulatory inspection readiness.
What We're Looking For
- Minimum of 1 year of clinically related experience.
- Minimum of 6 months experience in clinical research monitoring of investigational drug or device trials.
- Familiarity with risk‐based monitoring approach, onsite and offsite monitoring.
- 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 in a dynamic environment with competing projects and deadlines.
- Advanced ability to leverage technology, tools, and resources to provide customer centric support.
- Strong interpersonal skills with excellent written, verbal, active listening, and presentation skills.
- Ability to use functional expertise, 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.
Nice to Have
- Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing).
- Knowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
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.
