[Remote] Clinical Research Associate II - Oncology (Remote US - Multiple Openings)

Note: The job is a remote job and is open to candidates in USA. AbbVie is a company dedicated to discovering and delivering innovative medicines and solutions to address serious health issues. They are seeking a Clinical Research Associate II to advance their clinical research pipeline, ensuring effective trial conduct and improving data integrity and compliance. The role involves partnering with investigators, training site staff, and conducting site evaluations to enhance overall study performance.ResponsibilitiesConsidered as the primary point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie’s positioningAligns, 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 partnershipConducts site evaluation, site training, routine, 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 subjectsAdvanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategyAdvanced 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 compliancePossesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their developmentMay participate in global/local task forces and initiatives. Responsible for activities as assigned by managerResponsible 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 issuesAdvanced 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 customer centric approachIdentifies, evaluates and recommends new/potential investigators/sites on an ongoing basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigatorsEnsures 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 timesManages investigator payments as per executed contract obligations, as applicableSkillsAppropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferredMinimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. Familiar with risk‐based monitoring approach, onsite and offsite monitoringKnowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trialsAdvanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policiesDemonstrate strong cross-functional collaboration skills among internal and external stakeholdersDemonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlinesAdvanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the siteStrong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and trainingAbility to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issuesActs 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 environmentBenefitsPaid time off (vacation, holidays, sick)Medical/dental/vision insurance401(k) to eligible employeesThis job is eligible to participate in our short-term incentive programs.Company OverviewAbbVie is a biopharmaceutical company focused on immunology, oncology, neuroscience, virology, and aesthetics. It is a sub-organization of AbbVie. It was founded in 2013, and is headquartered in North Chicago, Illinois, USA, with a workforce of 10001+ employees. Its website is https://www.abbvie.com.Company H1B SponsorshipAbbVie has a track record of offering H1B sponsorships, with 41 in 2026, 273 in 2025, 190 in 2024, 225 in 2023, 284 in 2022, 186 in 2021, 186 in 2020. Please note that this does not guarantee sponsorship for this specific role.