Clinical Research Associate II

Company Description About AbbVie 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube. OurGreat Place to WorkCertification highlights our dedication to cultivating a high-trust, and inclusive culture for all. At AbbVie, youwon'tjust have ajob,youllhave the opportunity to unlock a bright future, becausewe'renot just a workplace;we'rea world of possibilities. Difference makers wanted. Apply now! Whats In It for You? Innovative work culture Professional development Paid time off: vacation, holidays, personal days, and volunteer days Employee stock purchase Wellness spending account Flexible health insurance Retirement savings programs Bonus plan Job Description To enable AbbVie s emergence as a world class R&D organization, the position anticipates and proactively solves study-related clinical site issues as they occur and initiates, recommends and communicates corrective action ensuring successful protocol level execution of Clinical Site Management deliverables involving start-up, execution, and close-out of studies. Key Responsibilities Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase I to III studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes. Overviews the overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives. proactively manages the site and ensures action plans are put into place as needed to ensure compliance. Ensures regulatory inspection readiness at assigned clinical sites. 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 safety and protection of study subjects through compliance with the study monitoring plan, AbbVie SOPs, ICH Guidelines, and applicable regulations. Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members. Manages investigator payments as per executed contract obligations. Negotiates investigator/ hospital agreements with stakeholders. Maintain and complete own expense reports as per local and applicable guidelines. Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators. Qualifications Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing) preferred. Minimum of 2 years of clinically-related monitoring experience. Experience in on-site monitoring of investigational drug or device trials is required. Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials. Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations. Familiarity with all aspects of study monitoring; data, drug accountability, documentation experience. Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. Ability to work, understand and follow work processes within the assigned function. Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity. Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated. Ability to use functional expertise and exercise good judgment. Demonstrated business ethics and integrity. A minimum of 50% travel is required. Proficient with Microsoft Office Suite (Outlook, PowerPoint, Excel, Word, etc.) Must be at ease with technology (the use of various tools/systems to perform day-to-day tasks). Travel required at least 50% of the time. Valid drivers license and passport. Additional Information 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 only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

The role involves monitoring clinical investigative sites to ensure protocol execution and adherence to federal regulations and GCP guidelines. Key duties include conducting site visits, managing data quality, and overseeing the safety and protection of study subjects.

Candidates must have at least 2 years of clinical monitoring experience and a health-related tertiary qualification. A valid driver's license, passport, and the ability to travel at least 50% of the time are required.

• Professional development • Paid time off • Vacation • Holidays • Personal days • Volunteer days • Employee stock purchase • Wellness spending account • Flexible health insurance • Retirement savings programs • Bonus plan

• Gestion de projetSouhaitée

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Clinical Site Management
• Clinical Monitoring
• Good Clinical Practice (GCP)
• ICH Guidelines
• Site Qualification
• Regulatory Compliance
• Data Quality Assurance
• Patient Safety Monitoring
• Investigator Training
• Contract Negotiation
• Microsoft Office Suite
• Analytical Skills
• Interpersonal Communication
• Organizational Skills
• Project Management

• Science & Research
• Healthcare

Formation minimale

Baccalauréat

Expérience minimale

2+ ans

Postuler avant le

14 sept. 2026

Langue de l’offre

anglais

Heures de travail

40 heures par semaine

Niveau d’expérience

Mid-Senior level