Clinical Research Associate II – Oncology

This is a fully remote position, open to applicants in Connecticut.

📋 Description

• Propel AbbVie's clinical research initiatives by pursuing excellence in clinical research.

• Collaborate with investigators and site personnel to facilitate meaningful and effective clinical trial interactions.

• Act as the primary liaison for investigative sites.

• Provide contextual insights on clinical trials and connect stakeholders with investigative sites.

• Align, train, and motivate site personnel and principal investigators regarding trial objectives, protocols, and patient treatment principles.

• Conduct site evaluations, site training, regular monitoring, and site closure monitoring.

• Ensure adherence to protocols, monitoring plans, applicable regulations, GCPs, ICH Guidelines, SOPs, and quality standards.

• Develop and personalize site engagement strategies for designated studies.

• Collect local and site insights and utilize CRM tools to report, track, and assess strategy effectiveness.

• Assess and ensure the implementation of effective patient recruitment and retention strategies based on the patient disease journey.

• Cultivate knowledge of therapeutic areas, assets, clinical landscapes, and patient journeys to support recruitment and protocol adherence.

• Mentor and train junior CRAs while providing developmental feedback.

• Engage in global or local task forces and initiatives.

• Perform ongoing risk assessments with the Central Monitoring team to pinpoint study performance or patient safety concerns.

• Address site risk signals and execute preventative and corrective action plans.

• Identify, evaluate, and recommend clinical investigators and sites.

• Ensure the quality and timely submission of site data, including safety event reporting and follow-ups.

• Maintain readiness for audits and regulatory inspections at assigned sites.

• Manage investigator payments in accordance with executed contract obligations, as necessary.

⛳️ Requirements

• Relevant tertiary qualification in health-related fields (Medical, Scientific, Nursing) is preferred.

• A minimum of 1 year of experience in clinically related roles.

• At least 6 months of experience in clinical research monitoring involving investigational drug or device trials.

• Familiarity with risk-based monitoring, both onsite and offsite.

• Preferred knowledge of therapeutic area indications.

• Advanced understanding of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.

• Strong skills in cross-functional collaboration.

• Excellent planning and organizational abilities.

• Capability to work efficiently in a dynamic environment with competing projects and deadlines.

• Advanced proficiency in leveraging technology, tools, and resources.

• Exceptional interpersonal skills along with excellent written, verbal, active listening, and presentation abilities.

• Ability to establish and foster site relationships and trusted partnerships.

• Capacity to apply critical thinking and sound judgment to resolve clinical site challenges.

• Integrity aligned with AbbVie’s code of business conduct and leadership values.

• Self-motivated and focused on achieving timely, high-quality outcomes.

🏝️ Benefits

• Paid time off (vacation, holidays, sick leave).

• Medical, dental, and vision insurance.

• 401(k) retirement plan.

• Short-term incentive programs.

• Commitment to equal opportunity employment.

• Reasonable accommodations for applicants.

• Commitment to hiring veterans and individuals with disabilities.