Clinical Research Associate I - Neurology (Los Angeles/Orange County Area)

AbbVie discovers and delivers innovative medicines and solutions that address serious health issues and medical challenges across therapeutic areas including neuroscience. The Clinical Research Associate I will support clinical trial execution in neurology by partnering with investigative sites, ensuring protocol compliance and data integrity, monitoring study performance, and protecting patient safety.

Responsibilities

Considered as the primary point of contact for the investigative site, provides 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 under supervision 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 under supervision, in compliance to the protocol and monitoring plans and accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to quality standards in conducting clinical research, ensuring safety and protection of study subjects

Customize site engagement strategy for assigned study(ies) under supervision. 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

Fundamental 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

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. 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 under supervision and support from more experienced CRAs

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

Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing)

experience or equivalent work experience

preferably in clinical research coordinating or data management

Knowledge of appropriate therapeutic area indications

with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials

Health-related Tertiary Qualification

Medical Qualification

Scientific Qualification

Nursing Qualification

Clinical Research Coordination

Clinical Data Management

Therapeutic Area Knowledge

Scientific Concepts

Clinical Trial Conduct

Benefits

Paid time off (vacation, holidays, sick) for eligible employees

Medical, dental, and vision insurance for eligible employees

401(k) for eligible employees

Eligibility to participate in short-term incentive programs

Company

Global biopharmaceutical company developing medicines for immunology, oncology, neuroscience, aesthetics.

North Chicago, Illinois, USA

https://www.abbvie.com/

Founded in 2013

10001+ employees

Qualifications

Clinically related experience

Knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies

Able to work collaboratively and cross functionally to develop and sustain working relationships

Demonstrate planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines

Ability to leverage technology, tools and resources to provide customer centric support based on the health of the site

Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues

Interpersonal skills with strong written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training

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

Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing)

Experience or equivalent work experience

Preferably in clinical research coordinating or data management

Knowledge of appropriate therapeutic area indications

With the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials

Required skills

Clinical Research, Clinical Research Coordination, Clinical Data Management, Neurology, Clinical Trial Requirements, ICH/GCP Guidelines, Clinical Research Regulations, Scientific Concepts

Preferred skills

experience or equivalent work experience, Knowledge of appropriate therapeutic area indications

Experience

Entry level