Clinical Research Associate II – Oncology

Job not on LinkedIn

🔥 0 minutes ago

🧀 Wisconsin – Remote

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⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🚫👨‍🎓 No degree required

👻 Ghost score 25%

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Lifelancer

51 - 200 employees

Founded 2020

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Pre Seed Round on 2022-03

Consulting • Healthcare • Logistics

Lifelancer is an AI-powered talent hiring platform that connects employers with skilled professionals in the Life Sciences, Pharmaceutical, and IT sectors. It enables individuals to create profiles showcasing their skills, get matched with high-paying international jobs or projects, and facilitates hiring and payroll for employers in multiple countries. The platform aims to streamline the hiring process with efficient AI sourcing and compliance support.

📋 Description

• Advance AbbVie’s clinical research pipeline and translate science into medicine for patients • Serve as the primary point of contact for investigative sites • Provide contextual information about clinical trials and connect stakeholders with investigative sites • Align, train, and motivate site staff and principal investigators on trial goals, protocols, and patient-treatment principles • Conduct site evaluation, site training, routine monitoring, and site closure activities • Ensure compliance with protocols, monitoring plans, regulations, GCP, ICH Guidelines, AbbVie SOPs, and quality standards • Customize site-engagement strategies and track progress using CRM tools • Support clinical trial execution by connecting protocols, scientific principles, and trial requirements to daily activities • Evaluate recruitment and retention plans based on the patient disease journey • Develop therapeutic-area, asset, clinical-landscape, and patient-journey knowledge • Mentor and train less experienced CRAs and contribute to their development • Participate in global/local task forces and initiatives • Perform continuous risk assessments with the Central Monitoring team • Resolve site risk signals and implement preventative and corrective action plans • Identify, evaluate, and recommend investigators and sites for clinical studies • Ensure timely, accurate site data submission and appropriate safety-event reporting and follow-up • Maintain audit and regulatory inspection readiness at assigned sites • Manage investigator payments according to executed contracts, as applicable

🎯 Requirements

• Appropriate tertiary qualification in health-related disciplines (Medical, Scientific, Nursing) preferred • Minimum of 1 year of clinically related experience • At least 6 months of clinical research monitoring experience for investigational drug or device trials • Familiarity with risk-based monitoring, onsite and offsite monitoring • Knowledge of relevant therapeutic area indications preferred • Ability to understand and apply scientific concepts to clinical trial conduct • Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies • Strong cross-functional collaboration skills • Strong planning and organizational skills; ability to manage competing projects and deadlines • Advanced ability to leverage technology, tools, and resources • Strong interpersonal, written, verbal, active listening, and presentation skills • Ability to establish site relationships and trusted partnerships through engagement, motivation, and training • Ability to apply critical thinking and good judgment to clinical site issues • Ability to act with integrity according to AbbVie’s code of business conduct and leadership values • Self-motivated and focused on timely, quality outcomes in a fast-paced environment

🏖️ Benefits

• Paid time off (vacation, holidays, sick) • Medical, dental, and vision insurance • 401(k) • Eligibility to participate in short-term incentive programs • Equal opportunity employer • Reasonable accommodation support for applicants with disabilities

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