Clinical Research Associate II

🔥 3 hours ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

AbbVie

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2013

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.

📋 Description

• Anticipates and proactively solves study-related clinical site issues as they occur and initiates, recommends, and communicates corrective action to ensure successful protocol-level execution of Clinical Operations deliverables involving start-up, execution, and close-out of studies. • 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 quality standards in conducting clinical research. • Conducts site qualification, initiation, interim monitoring, and study closeout visits for Phase 1–4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie SOPs, and business processes. • Oversees 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. • Maintains and completes own expense reports as per local and applicable guidelines. • Identifies, evaluates, and recommends new/potential investigators/sites on an ongoing basis.

🎯 Requirements

• Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred. • Minimum 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 monitoring. • Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials. • Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies. • Demonstrate strong cross-functional collaboration skills among internal and external stakeholders. • Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. • Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site. • Strong 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 training. • Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues. • Acts 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 environment.

🏖️ Benefits

• AbbVie is an equal opportunity employer • Operating with integrity, driving innovation, transforming lives and serving our community. • Equal Opportunity Employer/Veterans/Disabled.