Clinical Research Associate

Considered as the primary Sponsor point of contact for the investigative site provides 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 with support as needed 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 on-site and off-site monitoring and site closure 
activities with support as needed 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) with support as needed. Gather 
local/site insights and utilize site engagement tracking tools 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.
Identifies evaluates and recommends new/potential investigators/sites with support as needed 
from more experienced Site Monitors.
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 (e.g. Medical Scientific Pharmacy
Nursing) preferred or experience or equivalent work experience.
Minimum of 3-5 years of direct monitoring experience in clinical trials with significant experience 
in interventional studies.
Previous experience managing sites in global clinical trials (multi-country studies) including start
-up monitoring and close-out activities.
Clinically related experience in clinical research coordinating or data management preferred.
Knowledge of appropriate therapeutic area indications is preferred with the ability to understand a
nd apply scientific concepts as they relate to the conduct of clinical trials.
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.
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.
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