Clinical Research Associate

Allergan Aesthetics, an AbbVie Company, is hiring a Clinical Research Associate to support clinical research and advance AbbVie’s pipeline. The role partners with investigators and site staff to oversee trial conduct, strengthen data integrity and compliance, support patient recruitment, and manage site performance and safety.

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

Preferred

Bachelor's Degree in health related disciplines (Medical, Scientific, Nursing) preferred

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

Health Sciences

Therapeutic Area Knowledge

Scientific Concepts

Clinical Trial Conduct

Benefits

Paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees

Eligible to participate in short-term incentive programs

Remote work

Company

Develops, manufactures, and markets aesthetic products for injectables, contouring, skincare

Irvine, California, USA

https://www.allerganaesthetics.com/

1001-5000 employees

Qualifications

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 risk‐based monitoring approach, onsite and off site 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 adynamic 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

*This position requires regular driving and eligibility to operate a company vehicle, subject to the applicable AbbVie policies and procedures

Bachelor's Degree in health related disciplines (Medical, Scientific, Nursing) preferred

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

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.

Required skills

Clinical Research Monitoring, Risk-Based Monitoring, Onsite and Off-Site Monitoring, Investigational Drug and Device Trials, ICH-GCP, Clinical Trial Regulatory Compliance, Therapeutic Area Knowledge

Preferred skills

Planning and Organizational Skills

Experience

1+ years