Clinical Research Associate II – Oncology

🕒 Yesterday

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $84.5k - $162k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🚫👨‍🎓 No degree required

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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AbbVie

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2013

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

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

• Advance AbbVie’s clinical research pipeline by driving excellence in clinical research and translating science into medicine • Partner with investigators and site staff to support effective clinical trial engagements • 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 monitoring • Ensure compliance with protocols, monitoring plans, applicable regulations, GCPs, ICH Guidelines, AbbVie SOPs, and quality standards • Develop and customize site engagement strategies; gather site insights and track progress using CRM tools • Support 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 or local task forces and initiatives • Perform continuous risk assessment with the Central Monitoring team to identify study performance or patient safety issues • Resolve site risk signals and implement preventative and corrective action plans • Identify and evaluate potential investigators and sites • Ensure quality and timely submission of site data and safety-event reporting • 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 therapeutic area indications preferred • 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 work effectively with competing projects and deadlines • Ability to leverage technology, tools, and resources for customer-centric site support • Strong interpersonal, written, verbal, active listening, and presentation skills • Ability to establish site relationships and trusted partnerships through engagement, motivation, and training • Critical thinking and good judgment to address 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 • Willingness and ability to travel 75% of the time

🏖️ Benefits

• Paid time off (vacation, holidays, sick) • Medical, dental, and vision insurance • 401(k) • Short-term incentive programs • Travel opportunities (role requires 75% travel)