Clinical Research Associate II
About The Position
Advance AbbVie's clinical pipeline by striving for excellence in clinical research, turning science into medicine for patients, and leveraging advanced capabilities to drive industry-leading performance. The Clinical Research Associate II partners with investigators and site staff to build meaningful, effective engagements and position AbbVie as a preferred clinical-trial partner. The role focuses on site clinical research, appropriate trial conduct, data integrity, compliance, study performance, and customer experience. As the primary point of contact for investigative sites, the associate supports and trains site staff, conducts monitoring activities, assesses risks, and helps ensure patient safety and protocol compliance. The role also supports site engagement strategies, recruitment and retention, data quality and timeliness, audit readiness, investigator payments where applicable, and the development of less experienced CRAs.
Requirements
- Minimum of 1 year of clinically related experience, including at least 6 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, with 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 support based on site health.
- 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 in accordance with AbbVie’s code of business conduct and leadership values.
- Self-motivation and focus on delivering timely, quality outcomes in a fast-paced environment.
Nice To Haves
- Tertiary qualification in a health-related discipline such as medical, scientific, or nursing.
- Knowledge of relevant therapeutic-area indications and ability to understand and apply scientific concepts to clinical-trial conduct.
Responsibilities
- Serve as the primary point of contact for investigative sites, providing contextual information about clinical trials and strengthening AbbVie’s positioning.
- Align, train, and motivate site staff and principal investigators on clinical-trial program goals, protocols, and patient-treatment principles.
- Conduct site evaluation, site training, routine monitoring, and site closure monitoring in accordance with protocols, monitoring plans, regulations, GCP, ICH Guidelines, AbbVie SOPs, and quality standards.
- Customize site engagement strategies for assigned studies, gather site insights, and use CRM tools to track progress and measure impact.
- Connect study protocols, scientific principles, and clinical-trial requirements to daily trial execution.
- Evaluate and support effective patient recruitment and retention techniques based on 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, and perform other activities assigned by the manager.
- Conduct ongoing risk assessment and collaborate with Central Monitoring to detect study-performance or patient-safety issues at clinical sites.
- Resolve site risk signals, establish preventative and corrective action plans as needed, and promote compliance through a customer-centric approach.
- 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 for safety events.
- Maintain audit and regulatory inspection readiness at assigned clinical sites.
- Manage investigator payments in accordance with executed contract obligations, as applicable.
Benefits
- Paid time off, including vacation, holidays, and sick leave.
- 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
