Senior Clinical Research Associate

Job Summary

Required Qualifications

• •Minimum of 3 years of clinically related experience
• •Period of 2 years in independent clinical research monitoring of investigational drug or device trials
• •Experience in any therapeutic area
• •Familiarity with risk-based monitoring approach
• •Experience with onsite and offsite monitoring
• •Knowledge of appropriate therapeutic area indications
• •Ability to understand and apply scientific concepts as they relate to the conduct of clinical trials
• •Superior knowledge on existing and emerging local regulatory and legal requirements
• •Knowledge of ICH/GCP Guidelines
• •Knowledge of applicable policies
• •Advanced communication skills
• •Superior cross-functional collaboration skills
• •Superior planning and organizational skills
• •Ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
• •Superior ability to leverage technology, tools and resources
• •Superior interpersonal skills
• •Excellent written, verbal, active listening and presentation skills
• •Ability to establish and leverage site relationships
• •Ability to motivate and align monitoring community
• •Ability to support, guide, and mentor junior personnel
• •Ability to independently listen to and consider viewpoints
• •Ability to think critically to resolve site risk signals
• •Ability to generate and ensure effective recruitment and retention techniques/plans
• •Ability to customize site engagement 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 detect early overall study performance or patient safety issues
• •Ability to put preventative and corrective action plans into place
• •Ability to independently use functional expertise
• •Ability to leverage critical thinking skills
• •Ability to apply good judgement to address clinical site issues
• •US & Puerto Rico location
• •Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Pharmacy, Nursing)

Desired Qualifications

• •Advanced level of competency or experience in providing contextual information on the clinical trials
• •Ability to connect stakeholders to the investigative sites
• •Ability to strengthen Abbvie's positioning
• •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 ensure safety and protection of study subjects
• •Ability to critically apply new strategies as needed
• •Ability to report/track progress
• •Ability to measure impact of site engagement strategy
• •Ability to generate and ensure effective recruitment and retention techniques/plans based on the patient disease journey
• •Solid knowledge of therapeutic area
• •Solid knowledge of asset and clinical landscape
• •Solid knowledge of patient journey
• •Ability to enable successful patient recruitment
• •Ability to enable overall protocol compliance
• •Advanced level of competency to mentor and train less experienced CRAs
• •Ability to provide input into their development
• •Ability to support local onboarding of more junior CRAs
• •Ability to participate/lead in global/local task forces and initiatives
• •Ability to proactively conduct continuous risk-assessment
• •Ability to monitor activities conducted by clinical sites
• •Ability to detect early overall study performance or patient safety issues
• •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 and promote compliance
• •Ability to independently identify, evaluate and recommend new/potential investigators/sites
• •Expert understanding and decision making
• •Ability to identify potential sites through networking
• •Ability to assist in the placement of planned clinical studies with qualified investigators
• •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 ensure audit and regulatory inspection readiness at assigned clinical site
• •Ability to manage investigator payments
• •Appropriate tertiary qualification in health related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred
• •Period of 2 years preferable in independent clinical research monitoring of investigational drug or device trials
• •Superior knowledge on existing and emerging local regulatory and legal requirements
• •Knowledge of ICH/GCP Guidelines
• •Knowledge of applicable policies
• •Advanced communication skills
• •Superior cross-functional collaboration skills
• •Superior planning and organizational skills
• •Ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
• •Superior ability to leverage technology, tools and resources
• •Superior interpersonal skills
• •Excellent written, verbal, active listening and presentation skills
• •Ability to establish and leverage site relationships
• •Ability to motivate and train site staff and principal investigator
• •Ability to ensure a trusted partnership
• •Ability to support, guide, and mentor junior personnel on Site Management activities
• •Ability to conduct site evaluation
• •Ability to conduct site training
• •Ability to conduct routine on-site and off-site monitoring
• •Ability to conduct site closure monitoring activities
• •Compliance to the protocol and monitoring plans
• •Compliance with applicable regulations
• •Compliance with Good Clinical Practices (GCPs)
• •Compliance with ICH Guidelines
• •Compliance with AbbVie Standard Operating Procedures (SOPs)
• •Compliance with quality standards
• •Ability to demonstrate advanced communication skills
• •Ability to demonstrate superior cross-functional collaboration skills
• •Ability to demonstrate superior planning and organizational skills
• •Ability to demonstrate the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
• •Ability to demonstrate superior ability to leverage technology, tools and resources
• •Ability to demonstrate superior interpersonal skills
• •Ability to demonstrate excellent written, verbal, active listening and presentation skills
• •Ability to demonstrate the ability to establish and leverage site relationships
• •Ability to demonstrate the ability to motivate and train site staff and principal investigator
• •Ability to demonstrate the ability to ensure a trusted partnership
• •Ability to demonstrate the ability to support, guide, and mentor junior personnel on Site Management activities
• •Ability to demonstrate the ability to conduct site evaluation
• •Ability to demonstrate the ability to conduct site training
• •Ability to demonstrate the ability to conduct routine on-site and off-site monitoring
• •Ability to demonstrate the ability to conduct site closure monitoring activities
• •Ability to demonstrate compliance to the protocol and monitoring plans
• •Ability to demonstrate compliance with applicable regulations
• •Ability to demonstrate compliance with Good Clinical Practices (GCPs)
• •Ability to demonstrate compliance with ICH Guidelines
• •Ability to demonstrate compliance with AbbVie Standard Operating Procedures (SOPs)
• •Ability to demonstrate compliance with quality standards
• •Ability to demonstrate the ability to think critically to resolve site risk signals
• •Ability to demonstrate the ability to have robust understanding of site processes
• •Ability to demonstrate the ability to drive study execution
• •Ability to demonstrate the ability to ensure preventative and corrective action plans are put into place
• •Ability to demonstrate the ability to mitigate risk and promote compliance
• •Ability to demonstrate the ability to independently identify, evaluate and recommend new/potential investigators/sites
• •Ability to demonstrate expert understanding and decision making
• •Ability to demonstrate the ability to identify potential sites through networking
• •Ability to demonstrate the ability to assist in the placement of planned clinical studies with qualified investigators
• •Ability to demonstrate the ability to ensure quality of data submitted from study sites
• •Ability to demonstrate the ability to assure timely submission of data
• •Ability to demonstrate the ability to provide appropriate reporting and follow-up for all safety events
• •Ability to demonstrate the ability to ensure audit and regulatory inspection readiness at assigned clinical site
• •Ability to demonstrate the ability to manage investigator payments
• •Ability to demonstrate the ability to detect early overall study performance or patient safety issues
• •Ability to demonstrate the ability to proactively conduct continuous risk-assessment
• •Ability to demonstrate the ability to monitor activities conducted by clinical sites
• •Ability to demonstrate the ability to think critically to resolve site risk signals
• •Ability to demonstrate the ability to have robust understanding of site processes
• •Ability to demonstrate the ability to drive study execution
• •Ability to demonstrate the ability to ensure preventative and corrective action plans are put into place
• •Ability to demonstrate the ability to mitigate risk and promote compliance
• •Ability to demonstrate the ability to independently identify, evaluate and recommend new/potential investigators/sites
• •Ability to demonstrate expert understanding and decision making
• •Ability to demonstrate the ability to identify potential sites through networking
• •Ability to demonstrate the ability to assist in the placement of planned clinical studies with qualified investigators
• •Ability to demonstrate the ability to ensure quality of data submitted from study sites
• •Ability to demonstrate the ability to assure timely submission of data
• •Ability to demonstrate the ability to provide appropriate reporting and follow-up for all safety events
• •Ability to demonstrate the ability to ensure audit and regulatory inspection readiness at assigned clinical site
• •Ability to demonstrate the ability to manage investigator payments
• •Ability to demonstrate the ability to detect early overall study performance or patient safety issues
• •Ability to demonstrate the ability to proactively conduct continuous risk-assessment
• •Ability to demonstrate the ability to monitor activities conducted by clinical sites
• •Ability to demonstrate the ability to think critically to resolve site risk signals
• •Ability to demonstrate the ability to have robust understanding of site processes
• •Ability to demonstrate the ability to drive study execution
• •Ability to demonstrate the ability to ensure preventative and corrective action plans are put into place
• •Ability to demonstrate the ability to mitigate risk and promote compliance
• •Ability to demonstrate the ability to independently identify, evaluate and recommend new/potential investigators/sites
• •Ability to demonstrate expert understanding and decision making
• •Ability to demonstrate the ability to identify potential sites through networking
• •Ability to demonstrate the ability to assist in the placement of planned clinical studies with qualified investigators
• •Ability to demonstrate the ability to ensure quality of data submitted from study sites
• •Ability to demonstrate the ability to assure timely submission of data
• •Ability to demonstrate the ability to provide appropriate reporting and follow-up for all safety events
• •Ability to demonstrate the ability to ensure audit and regulatory inspection readiness at assigned clinical site
• •Ability to demonstrate the ability to manage investigator payments
• •Ability to demonstrate the ability to detect early overall study performance or patient safety issues
• •Ability to demonstrate the ability to proactively conduct continuous risk-assessment
• •Ability to demonstrate the ability to monitor activities conducted by clinical sites
• •Ability to demonstrate the ability to think critically to resolve site risk signals
• •Ability to demonstrate the ability to have robust understanding of site processes
• •Ability to demonstrate the ability to drive study execution
• •Ability to demonstrate the ability to ensure preventative and corrective action plans are put into place
• •Ability to demonstrate the ability to mitigate risk and promote compliance
• •Ability to demonstrate the ability to independently identify, evaluate and recommend new/potential investigators/sites
• •Ability to demonstrate expert understanding and decision making
• •Ability to demonstrate the ability to identify potential sites through networking
• •Ability to demonstrate the ability to assist in the placement of planned clinical studies with qualified investigators
• •Ability to demonstrate the ability to ensure quality of data submitted from study sites
• •Ability to demonstrate the ability to assure timely submission of data
• •Ability to demonstrate the ability to provide appropriate reporting and follow-up for all safety events
• •Ability to demonstrate the ability to ensure audit and regulatory inspection readiness at assigned clinical site
• •Ability to demonstrate the ability to manage investigator payments
• •Ability to demonstrate the ability to detect early overall study performance or patient safety issues
• •Ability to demonstrate the ability to proactively conduct continuous risk-assessment
• •Ability to demonstrate the ability to monitor activities conducted by clinical sites
• •Ability to demonstrate the ability to think critically to resolve site risk signals
• •Ability to demonstrate the ability to have robust understanding of site processes
• •Ability to demonstrate the ability to drive study execution
• •Ability to demonstrate the ability to ensure preventative and corrective action plans are put into place
• •Ability to demonstrate the ability to mitigate risk and promote compliance
• •Ability to demonstrate the ability to independently identify, evaluate and recommend new/potential investigators/sites
• •Ability to demonstrate expert understanding and decision making
• •Ability to demonstrate the ability to identify potential sites through networking
• •Ability to demonstrate the ability to assist in the placement of planned clinical studies with qualified investigators
• •Ability to demonstrate the ability to ensure quality of data submitted from study sites
• •Ability to demonstrate the ability to assure timely submission of data
• •Ability to demonstrate the ability to provide appropriate reporting and follow-up for all safety events
• •Ability to demonstrate the ability to ensure audit and regulatory inspection readiness at assigned clinical site
• •Ability to demonstrate the ability to manage investigator payments
• •Ability to demonstrate the ability to detect early overall study performance or patient safety issues
• •Ability to demonstrate the ability to proactively conduct continuous risk-assessment
• •Ability to demonstrate the ability to monitor activities conducted by clinical sites
• •Ability to demonstrate the ability to think critically to resolve site risk signals
• •Ability to demonstrate the ability to have robust understanding of site processes
• •Ability to demonstrate the ability to drive study execution
• •Ability to demonstrate the ability to ensure preventative and corrective action plans are put into place
• •Ability to demonstrate the ability to mitigate risk and promote compliance
• •Ability to demonstrate the ability to independently identify, evaluate and recommend new/potential investigators/sites
• •Ability to demonstrate expert understanding and decision making
• •Ability to demonstrate the ability to identify potential sites through networking
• •Ability to demonstrate the ability to assist in the placement of planned clinical studies with qualified investigators
• •Ability to demonstrate the ability to ensure quality of data submitted from study sites
• •Ability to demonstrate the ability to assure timely submission of data
• •Ability to demonstrate the ability to provide appropriate reporting and follow-up for all safety events
• •Ability to demonstrate the ability to ensure audit and regulatory inspection readiness at assigned clinical site
• •Ability to demonstrate the ability to manage investigator payments
• •Ability to demonstrate the ability to detect early overall study performance or patient safety issues
• •Ability to demonstrate the ability to proactively conduct continuous risk-assessment
• •Ability to demonstrate the ability to monitor activities conducted by clinical sites
• •Ability to demonstrate the ability to think critically to resolve site risk signals
• •Ability to demonstrate the ability to have robust understanding of site processes
• •Ability to demonstrate the ability to drive study execution
• •Ability to demonstrate the ability to ensure preventative and corrective action plans are put into place
• •Ability to demonstrate the ability to mitigate risk and promote compliance
• •Ability to demonstrate the ability to independently identify, evaluate and recommend new/potential investigators/sites
• •Ability to demonstrate expert understanding and decision making
• •Ability to demonstrate the ability to identify potential sites through networking
• •Ability to demonstrate the ability to assist in the placement of planned clinical studies with qualified investigators
• •Ability to demonstrate the ability to ensure quality of data submitted from study sites
• •Ability to demonstrate the ability to assure timely submission of data
• •Ability to demonstrate the ability to provide appropriate reporting and follow-up for all safety events
• •Ability to demonstrate the ability to ensure audit and regulatory inspection readiness at assigned clinical site
• •Ability to demonstrate the ability to manage investigator payments
• •Ability to demonstrate the ability to detect early overall study performance or patient safety issues
• •Ability to demonstrate the ability to proactively conduct continuous risk-assessment
• •Ability to demonstrate the ability to monitor activities conducted by clinical sites
• •Ability to demonstrate the ability to think critically to resolve site risk signals
• •Ability to demonstrate the ability to have robust understanding of site processes
• •Ability to demonstrate the ability to drive study execution
• •Ability to demonstrate the ability to ensure preventative and corrective action plans are put into place
• •Ability to demonstrate the ability to mitigate risk and promote compliance
• •Ability to demonstrate the ability to independently identify, evaluate and recommend new/potential investigators/sites
• •Ability to demonstrate expert understanding and decision making
• •Ability to demonstrate the ability to identify potential sites through networking
• •Ability to demonstrate the ability to assist in the placement of planned clinical studies with qualified investigators
• •Ability to demonstrate the ability to ensure quality of data submitted from study sites
• •Ability to demonstrate the ability to assure timely submission of data
• •Ability to demonstrate the ability to provide appropriate reporting and follow-up for all safety events
• •Ability to demonstrate the ability to ensure audit and regulatory inspection readiness at assigned clinical site
• •Ability to demonstrate the ability to manage investigator payments
• •Ability to demonstrate the ability to detect early overall study performance or patient safety issues
• •Ability to demonstrate the ability to proactively conduct continuous risk-assessment
• •Ability to demonstrate the ability to monitor activities conducted by clinical sites
• •Ability to demonstrate the ability to think critically to resolve site risk signals
• •Ability to demonstrate the ability to have robust understanding of site processes
• •Ability to demonstrate the ability to drive study execution
• •Ability to demonstrate the ability to ensure preventative and corrective action plans are put into place
• •Ability to demonstrate the ability to mitigate risk and promote compliance
• •Ability to demonstrate the ability to independently identify, evaluate and recommend new/potential investigators/sites
• •Ability to demonstrate expert understanding and decision making
• •Ability to demonstrate the ability to identify potential sites through networking
• •Ability to demonstrate the ability to assist in the placement of planned clinical studies with qualified investigators
• •Ability to demonstrate the ability to ensure quality of data submitted from study sites
• •Ability to demonstrate the ability to assure timely submission of data