Allergan Aesthetics, an AbbVie Company · 9 hours ago
Clinical Research Associate ll - Oncology (North Carolina/South Carolina)
United States
Full-time
Remote
Entry, Mid Level
$82K/yr - $158K/yr
1+ years expAbbVie is a company dedicated to discovering and delivering innovative medicines and solutions that address serious health issues. The Clinical Research Associate II will advance AbbVie's pipeline by ensuring proper trial conduct and improving data integrity, compliance, and overall study performance while partnering with site staff and investigators.
BeautyManufacturingPharmaceuticalWellness
Responsibilities
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 AbbVie’s 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
Qualification
Required
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. (CRA experience)
Familiar 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 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
Preferred
Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred
Knowledge of appropriate therapeutic area indications (oncology) is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials
Experience as a study coordinator
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Short-term incentive programs
Long-term incentive programs
Company
Allergan Aesthetics, an AbbVie Company
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Nicole Mowad-Nassar
Senior Vice President, AbbVie and President, Global Allergan Aesthetics
Recent News
2025-12-04
Company data provided by crunchbase