Clinical Research Associate II - Oncology (D.C/Virginia)
About The Position
The Clinical Research Associate II advances AbbVie’s clinical research pipeline by partnering with investigators and site staff to support effective clinical trial conduct. The role serves as the primary point of contact for assigned investigative sites and promotes site engagement, data integrity, compliance, study performance, patient safety, and a positive customer experience. It conducts site evaluation, training, routine monitoring, and site closure activities in accordance with protocols, monitoring plans, applicable regulations, Good Clinical Practice (GCP), ICH Guidelines, AbbVie SOPs, and quality standards. The CRA develops knowledge of the therapeutic area, asset, clinical landscape, and patient journey to support recruitment, retention, and protocol compliance; assesses and mitigates site risks; supports audit and inspection readiness; and may mentor less experienced CRAs or participate in task forces and initiatives. The position requires at least one year of clinically related experience, including at least six months monitoring investigational drug or device trials, and familiarity with risk-based, onsite, and offsite monitoring. A tertiary qualification in a health-related discipline is preferred. The posted annual base salary range is USD 78,500–141,000. AbbVie offers paid time off, medical, dental, and vision insurance, a 401(k), and eligibility to participate in short-term incentive programs.
Requirements
- At least one year of clinically related experience, including at least six months in clinical research monitoring of investigational drug or device trials.
- Familiarity with risk-based monitoring and onsite and offsite monitoring.
- Advanced knowledge of existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.
- Strong cross-functional collaboration skills with internal and external stakeholders.
- Strong planning and organizational skills, including the ability to work effectively in a dynamic environment with competing projects and deadlines.
- Ability to leverage technology, tools, and resources to provide customer-centric site support.
- Strong interpersonal skills and excellent written, verbal, active listening, and presentation skills.
- Ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.
- Ability to apply functional expertise, critical thinking, and sound judgment to address clinical-site issues.
- Integrity consistent with AbbVie’s code of business conduct and leadership values; self-motivation and focus on timely, quality outcomes in a fast-paced environment.
Nice To Haves
- Tertiary qualification in a health-related discipline, such as medical, scientific, or nursing, is preferred.
- Knowledge of relevant therapeutic-area indications and the ability to understand and apply scientific concepts to clinical trial conduct.
Responsibilities
- Serve as the primary point of contact for investigative sites and provide contextual information about clinical trials.
- Align, train, and motivate site staff and principal investigators on trial goals, protocols, and patient-treatment principles.
- Conduct site evaluation, training, routine monitoring, and site closure monitoring in compliance with protocols, monitoring plans, regulations, GCP, ICH Guidelines, AbbVie SOPs, and quality standards.
- Customize site engagement strategies, gather site insights, and use CRM tools to track progress and measure impact.
- Connect protocol and scientific principles to clinical trial execution and evaluate recruitment and retention plans in light of the patient disease journey.
- Develop therapeutic-area, asset, clinical-landscape, and patient-journey knowledge to support recruitment and protocol compliance.
- Mentor and train less experienced CRAs and provide input into their development.
- Participate in global or local task forces and initiatives as assigned by the manager.
- Continuously assess risk and collaborate with the Central Monitoring team to detect study-performance or patient-safety issues at clinical sites.
- Resolve site risk signals and ensure preventive and corrective action plans are implemented as needed.
- Identify, evaluate, and recommend potential investigators and sites for planned clinical studies.
- Ensure the quality and timely submission of site data, including appropriate reporting and follow-up of safety events.
- Maintain audit and regulatory inspection readiness at assigned sites.
- Manage investigator payments according to executed contract obligations, as applicable.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in short-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
