Clinical Research Associate

Job Summary

Required Qualifications

• •Minimum of 1 year of clinically related experience
• •Period of 6 months in clinical research monitoring of investigational drug or device trials
• •Familiarity with risk-based monitoring approach
• •Familiarity with onsite and offsite monitoring
• •Advanced knowledge on existing and emerging local regulatory and legal requirements
• •Knowledge of ICH/GCP Guidelines
• •Knowledge of applicable policies
• •Ability to use functional expertise with appropriate guidance
• •Ability to leverage critical thinking skills
• •Ability to apply good judgement to address clinical site issues
• •Ability to establish and leverage site relationships
• •Ability to motivate and train
• •Ability to report/track progress
• •Ability to measure impact of strategy
• •Ability to identify, evaluate and recommend new/potential investigators/sites
• •Ability to ensure audit and regulatory inspection readiness
• •Ability to manage investigator payments
• •Ability to ensure quality of data submitted from study sites
• •Ability to assure timely submission of data
• •Ability to provide appropriate reporting and follow-up for all safety events
• •Ability to conduct site evaluation
• •Ability to conduct site training
• •Ability to conduct routine monitoring activities
• •Ability to conduct site closure monitoring activities
• •Ability to monitor activities conducted by clinical sites
• •Ability to detect early overall study performance or patient safety issues
• •Ability to develop preventative and corrective action plans
• •Ability to mitigate risk
• •Ability to promote compliance
• •Ability to work effectively and efficiently in a dynamic environment
• •Ability to work with competing projects and deadlines
• •Ability to leverage technology, tools and resources
• •Ability to provide customer centric support
• •Ability to think critically
• •Ability to resolve site risk signals
• •Ability to drive study execution
• •Ability to ensure appropriate conduct of the trial
• •Ability to drive improvement in data integrity
• •Ability to drive improvement in compliance
• •Ability to drive improvement in overall study performance
• •Ability to drive improvement in customer experience
• •Ability to connect stakeholder to the investigative sites
• •Ability to strengthen AbbVie's positioning
• •Ability to align, train and motivate the site staff and principal investigator
• •Ability to ensure a trusted partnership
• •Ability to customize site engagement strategy
• •Ability to gather local/site insights
• •Ability to utilize site engagement tools
• •Ability to report/track progress
• •Ability to measure impact of strategy
• •Ability to evaluate and ensure effective recruitment and retention techniques/plans
• •Ability to develop solid knowledge of therapeutic area
• •Ability to develop solid knowledge of asset
• •Ability to develop solid knowledge of clinical landscape
• •Ability to develop solid knowledge of patient journey
• •Ability to enable successful patient recruitment
• •Ability to ensure protocol compliance
• •Ability to mentor and train less experienced CRAs
• •Ability to provide input into their development
• •Ability to participate in global/local task forces and initiatives
• •Ability to perform activities as assigned by manager
• •Ability to demonstrate strong cross-functional collaboration skills
• •Ability to demonstrate strong planning and organizational skills
• •Ability to establish and leverage site relationships
• •Ability to provide trusted partnerships
• •Ability to engage
• •Ability to motivate
• •Ability to train
• •Ability to demonstrate strong interpersonal skills
• •Ability to demonstrate excellent written skills
• •Ability to demonstrate excellent verbal skills
• •Ability to demonstrate active listening skills
• •Ability to demonstrate presentation skills
• •Ability to act with integrity
• •Ability to deliver timely and quality outcomes
• •Ability to work in a fast-paced environment

Desired Qualifications

• •Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing)
• •Knowledge of appropriate therapeutic area indications
• •Ability to understand and apply scientific concepts as they relate to the conduct of clinical trials
• •Advanced understanding of site engagement
• •Ability to customize site engagement strategy for assigned study (ies)
• •Ability to gather local/site insights
• •Ability to utilize site engagement tools such as the Customer Relationship Management (CRM) tool
• •Ability to report/track progress
• •Ability to 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
• •Ability to evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey
• •Ability to develop solid knowledge of therapeutic area
• •Ability to develop solid knowledge of asset
• •Ability to develop solid knowledge of clinical landscape
• •Ability to develop solid knowledge of patient journey
• •Ability to enable successful patient recruitment
• •Ability to ensure overall protocol compliance
• •Advanced ability to think critically to resolve site risk signals
• •Robust understanding of site processes
• •Ability to drive study execution
• •Ability to ensure preventative and corrective action plans are put into place
• •Ability to mitigate risk
• •Ability to promote compliance
• •Customer centric approach
• •Advanced ability to leverage technology, tools and resources
• •Ability to provide customer centric support
• •Based on the health of the site
• •Self-motivated individual
• •Focused on delivering timely and quality outcomes
• •In a fast-paced environment