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AbbVie logo

Clinical Research Associate II

AbbVie

Clinical Research Associate II

AbbVie logo

AbbVie

full-time

Posted: November 7, 2025

Number of Vacancies: 1

Job Description

PurposeDescribe the primary goals, objectives or functions or outputs of this position.Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging advanced capabilities to drive industry leading performance. Partners with study teams, AbbVie internal R&D stakeholders, investigators, and site staff for meaningful and effective engagements positioning AbbVie as the partner of choice in clinical trials. Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.ResponsibilitiesList up to 10 main responsibilities for the job. Include information about the accountability and scope."Considered as the Pprimary Sponsor pPoint of contact for the investigative site. Advanced level of competency or experience in providing contextual information on the clinical trials, connecting stakeholders to the investigative sites and strengthening Abbvie's positioning. Ability to motivate and align monitoring community through leadership and mentorship."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. Able to support, guide, and mentor junior personnel on Site Management activities."Conducts site evaluation, site training, routine on-site and off-site monitoring, 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.Superior understanding of site engagement and ability to customize site engagement strategy for assigned study/ies and critically apply new strategies as needed. Gather local/site insights and utilize site engagement tools to report/track progress and measure impact of that strategy.Superior level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Expert understanding to generate 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 advanced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. Supports local onboarding of more junior CRAs. Demonstrates ability to openly listen to and consider viewpoints to enhance outcomes.May participate/lead 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. Superior 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 custIndependently Identifies, evaluates and recommends new/potential investigators/sites on an on going basis demonstrating expert understanding and decision making. 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.

Locations

  • Shanghai, Shanghai

Salary

Salary not disclosed

Estimated Salary Rangemedium confidence

120,000 - 160,000 USD / yearly

Source: AI estimated from job description

* This is an estimated range based on market data and may vary based on experience and qualifications.

Skills Required

  • Clinical research and monitoring expertiseintermediate
  • Site engagement and strategy customizationintermediate
  • Risk assessment and critical thinkingintermediate
  • Mentoring and leadershipintermediate
  • Regulatory compliance (GCPs, ICH, SOPs)intermediate
  • Patient recruitment and retention planningintermediate
  • Data quality management and audit readinessintermediate

Required Qualifications

  • Advanced level of competency or experience in providing contextual information on clinical trials, connecting stakeholders to investigative sites, and strengthening AbbVie's positioning (experience)
  • Superior understanding of site engagement and ability to customize site engagement strategy for assigned studies (experience)
  • Expert understanding of study protocol, scientific principles, and clinical trial requirements applied to day-to-day execution (experience)
  • Advanced competency in mentoring and training less experienced CRAs on various aspects of work (experience)
  • Superior ability to think critically to resolve site risk signals with robust understanding of site processes (experience)

Responsibilities

  • Serves as the primary sponsor point of contact for the investigative site, motivating and aligning monitoring community through leadership and mentorship
  • Aligns, trains, and motivates site staff and principal investigator on trial goals, protocol, and patient treatment principles to ensure trusted partnership
  • Conducts site evaluation, training, routine on-site and off-site monitoring, and site closure activities in compliance with regulations, GCPs, ICH Guidelines, AbbVie SOPs, and quality standards
  • Gathers local/site insights and utilizes site engagement tools to report/track progress and measure impact of customized strategies
  • Generates and ensures effective recruitment and retention techniques/plans based on patient disease journey, developing knowledge of therapeutic area, asset, and clinical landscape
  • Mentors and trains junior CRAs on site management activities, supports local onboarding, and provides input into their development
  • Participates/leads in global/local task forces and initiatives, responsible for activities assigned by manager
  • Performs continuous risk-assessment in collaboration with Central Monitoring team to detect early study performance or patient safety issues, implementing preventative and corrective actions
  • Independently identifies, evaluates, and recommends new/potential investigators/sites on an ongoing basis through networking or internal requests
  • Ensures quality of data submitted from sites, timely submission including safety event reporting, audit and regulatory inspection readiness, and manages investigator payments per contracts

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Research & DevelopmentAbbViePharmaceuticals

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AbbVie logo

Clinical Research Associate II

AbbVie

Clinical Research Associate II

AbbVie logo

AbbVie

full-time

Posted: November 7, 2025

Number of Vacancies: 1

Job Description

PurposeDescribe the primary goals, objectives or functions or outputs of this position.Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging advanced capabilities to drive industry leading performance. Partners with study teams, AbbVie internal R&D stakeholders, investigators, and site staff for meaningful and effective engagements positioning AbbVie as the partner of choice in clinical trials. Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.ResponsibilitiesList up to 10 main responsibilities for the job. Include information about the accountability and scope."Considered as the Pprimary Sponsor pPoint of contact for the investigative site. Advanced level of competency or experience in providing contextual information on the clinical trials, connecting stakeholders to the investigative sites and strengthening Abbvie's positioning. Ability to motivate and align monitoring community through leadership and mentorship."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. Able to support, guide, and mentor junior personnel on Site Management activities."Conducts site evaluation, site training, routine on-site and off-site monitoring, 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.Superior understanding of site engagement and ability to customize site engagement strategy for assigned study/ies and critically apply new strategies as needed. Gather local/site insights and utilize site engagement tools to report/track progress and measure impact of that strategy.Superior level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Expert understanding to generate 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 advanced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. Supports local onboarding of more junior CRAs. Demonstrates ability to openly listen to and consider viewpoints to enhance outcomes.May participate/lead 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. Superior 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 custIndependently Identifies, evaluates and recommends new/potential investigators/sites on an on going basis demonstrating expert understanding and decision making. 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.

Locations

  • Shanghai, Shanghai

Salary

Salary not disclosed

Estimated Salary Rangemedium confidence

120,000 - 160,000 USD / yearly

Source: AI estimated from job description

* This is an estimated range based on market data and may vary based on experience and qualifications.

Skills Required

  • Clinical research and monitoring expertiseintermediate
  • Site engagement and strategy customizationintermediate
  • Risk assessment and critical thinkingintermediate
  • Mentoring and leadershipintermediate
  • Regulatory compliance (GCPs, ICH, SOPs)intermediate
  • Patient recruitment and retention planningintermediate
  • Data quality management and audit readinessintermediate

Required Qualifications

  • Advanced level of competency or experience in providing contextual information on clinical trials, connecting stakeholders to investigative sites, and strengthening AbbVie's positioning (experience)
  • Superior understanding of site engagement and ability to customize site engagement strategy for assigned studies (experience)
  • Expert understanding of study protocol, scientific principles, and clinical trial requirements applied to day-to-day execution (experience)
  • Advanced competency in mentoring and training less experienced CRAs on various aspects of work (experience)
  • Superior ability to think critically to resolve site risk signals with robust understanding of site processes (experience)

Responsibilities

  • Serves as the primary sponsor point of contact for the investigative site, motivating and aligning monitoring community through leadership and mentorship
  • Aligns, trains, and motivates site staff and principal investigator on trial goals, protocol, and patient treatment principles to ensure trusted partnership
  • Conducts site evaluation, training, routine on-site and off-site monitoring, and site closure activities in compliance with regulations, GCPs, ICH Guidelines, AbbVie SOPs, and quality standards
  • Gathers local/site insights and utilizes site engagement tools to report/track progress and measure impact of customized strategies
  • Generates and ensures effective recruitment and retention techniques/plans based on patient disease journey, developing knowledge of therapeutic area, asset, and clinical landscape
  • Mentors and trains junior CRAs on site management activities, supports local onboarding, and provides input into their development
  • Participates/leads in global/local task forces and initiatives, responsible for activities assigned by manager
  • Performs continuous risk-assessment in collaboration with Central Monitoring team to detect early study performance or patient safety issues, implementing preventative and corrective actions
  • Independently identifies, evaluates, and recommends new/potential investigators/sites on an ongoing basis through networking or internal requests
  • Ensures quality of data submitted from sites, timely submission including safety event reporting, audit and regulatory inspection readiness, and manages investigator payments per contracts

Target Your Resume for "Clinical Research Associate II" , AbbVie

Get personalized recommendations to optimize your resume specifically for Clinical Research Associate II. Takes only 15 seconds!

AI-powered keyword optimization
Skills matching & gap analysis
Experience alignment suggestions

Check Your ATS Score for "Clinical Research Associate II" , AbbVie

Find out how well your resume matches this job's requirements. Get comprehensive analysis including ATS compatibility, keyword matching, skill gaps, and personalized recommendations.

ATS compatibility check
Keyword optimization analysis
Skill matching & gap identification
Format & readability score

Tags & Categories

Research & DevelopmentAbbViePharmaceuticals

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