BioSpace
Clinical Research Associate ll - Oncology (Remote - Oregon)
BioSpace, Oregon City, Oregon, United States, 97045
Clinical Research Associate II - Oncology (Remote - Oregon)
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Clinical Research Associate II - Oncology (Remote - Oregon)
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BioSpace Company Description AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and Tik Tok. Job Description The CRA II advances AbbVie’s pipeline by striving for excellence in clinical research, turning science into medicine for patients, and leveraging advanced capabilities to drive industry-leading performance. The CRA II partners with investigators and site staff to build meaningful, effective engagements that position AbbVie as the sponsor of choice in clinical trials. The role focuses on site clinical research by ensuring proper trial conduct, while continually working to improve data integrity, compliance, overall study performance, and the customer experience. Responsibilities Act as the primary point of contact for the investigative site. Align, train, and motivate site staff and principal investigator on the goals of the clinical trial program, protocol, and patient treatment principles. Conduct site evaluation, training, routine, and site closure monitoring activities in compliance with protocol and monitoring plans, applicable regulations, GCP, ICH Guidelines, AbbVie SOPs, and quality standards. Apply advanced engagement strategy customized for assigned studies, using tools such as CRM to report progress and measure impact. Translate study protocol and scientific principles into day‑to‑day execution, ensuring recruitment and retention techniques meet patient disease journey. Mentor less experienced CRAs and provide input into their development. Participate in global/local task forces and initiatives as assigned. Perform continuous risk assessment, collaborate with Central Monitoring to detect early study performance or safety issues. Recognize and mitigate site risk signals, develop corrective action plans, and promote compliance with a customer‑centric approach. Identify and recommend new investigators/sites, including through networking or internal AbbVie requests. Ensure quality of data submitted from sites and timely reporting of safety events. Maintain audit and regulatory inspection readiness at the assigned site. Manage investigator payments per executed contract obligations. Minimum Qualifications Minimum of 1 year of clinically related experience, including 6 months in clinical research monitoring of investigational drug or device trials. Familiar with risk‑based monitoring, onsite and offsite monitoring. Preferred Qualifications Appropriate tertiary qualification in health‑related disciplines (Medical, Scientific, Nursing). Knowledge of oncology therapeutic area and ability to apply scientific concepts to clinical trial conduct. Experience as a study coordinator. Other Required Skills Advanced knowledge of local regulatory and GCP Guidelines. Strong cross‑functional collaboration skills. Excellent planning and organizational skills for dynamic environment. Proficiency in leveraging technology and resources to support sites. Interpersonal, written, verbal, active listening, and presentation skills. Ability to use functional expertise with guidance, critical thinking, and good judgement to address site issues. Acts with integrity per AbbVie code of business conduct. Self‑motivated and focused on delivering timely, quality outcomes. Compensation and Benefits Pay range: $82,500 - $157,500 (Oregon City, OR). Paid time off (vacation, holidays, sick). Medical/dental/vision insurance. 401(k) retirement plan. Short‑term and long‑term incentive programs. Equal Opportunity Employer 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 applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
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Join to apply for the
Clinical Research Associate II - Oncology (Remote - Oregon)
role at
BioSpace Company Description AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and Tik Tok. Job Description The CRA II advances AbbVie’s pipeline by striving for excellence in clinical research, turning science into medicine for patients, and leveraging advanced capabilities to drive industry-leading performance. The CRA II partners with investigators and site staff to build meaningful, effective engagements that position AbbVie as the sponsor of choice in clinical trials. The role focuses on site clinical research by ensuring proper trial conduct, while continually working to improve data integrity, compliance, overall study performance, and the customer experience. Responsibilities Act as the primary point of contact for the investigative site. Align, train, and motivate site staff and principal investigator on the goals of the clinical trial program, protocol, and patient treatment principles. Conduct site evaluation, training, routine, and site closure monitoring activities in compliance with protocol and monitoring plans, applicable regulations, GCP, ICH Guidelines, AbbVie SOPs, and quality standards. Apply advanced engagement strategy customized for assigned studies, using tools such as CRM to report progress and measure impact. Translate study protocol and scientific principles into day‑to‑day execution, ensuring recruitment and retention techniques meet patient disease journey. Mentor less experienced CRAs and provide input into their development. Participate in global/local task forces and initiatives as assigned. Perform continuous risk assessment, collaborate with Central Monitoring to detect early study performance or safety issues. Recognize and mitigate site risk signals, develop corrective action plans, and promote compliance with a customer‑centric approach. Identify and recommend new investigators/sites, including through networking or internal AbbVie requests. Ensure quality of data submitted from sites and timely reporting of safety events. Maintain audit and regulatory inspection readiness at the assigned site. Manage investigator payments per executed contract obligations. Minimum Qualifications Minimum of 1 year of clinically related experience, including 6 months in clinical research monitoring of investigational drug or device trials. Familiar with risk‑based monitoring, onsite and offsite monitoring. Preferred Qualifications Appropriate tertiary qualification in health‑related disciplines (Medical, Scientific, Nursing). Knowledge of oncology therapeutic area and ability to apply scientific concepts to clinical trial conduct. Experience as a study coordinator. Other Required Skills Advanced knowledge of local regulatory and GCP Guidelines. Strong cross‑functional collaboration skills. Excellent planning and organizational skills for dynamic environment. Proficiency in leveraging technology and resources to support sites. Interpersonal, written, verbal, active listening, and presentation skills. Ability to use functional expertise with guidance, critical thinking, and good judgement to address site issues. Acts with integrity per AbbVie code of business conduct. Self‑motivated and focused on delivering timely, quality outcomes. Compensation and Benefits Pay range: $82,500 - $157,500 (Oregon City, OR). Paid time off (vacation, holidays, sick). Medical/dental/vision insurance. 401(k) retirement plan. Short‑term and long‑term incentive programs. Equal Opportunity Employer 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 applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
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