Clinical Research Associate I

Job summary

The Clinical Research Associate acts as the primary point of contact for investigative sites, ensuring trial conduct, data integrity, and compliance with protocols and regulations. They also develop site engagement strategies, mentor junior staff, and proactively manage site risks to ensure study performance and patient safety.

Job details

Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Our Great Place to Work® Certification highlights our dedication to cultivating a high-trust, and inclusive culture for all. At AbbVie, you won't just have a job, you’ll have the opportunity to unlock a bright future, because we're not just a workplace; we're a world of possibilities. Difference makers wanted. Apply now! What’s In It for You? Innovative work culture Professional development Paid time off: vacation, holidays, personal days, and volunteer days Employee stock purchase Wellness spending account Flexible health insurance Retirement savings programs Bonus plan Job Description Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry leading performance. Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials. Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience. Responsibilities: Considered as the primary point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie’s positioning. Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership. Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects. Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy. Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance. Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager. Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach. Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators. Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. Ensures audit and regulatory inspection readiness at assigned clinical site at all times. Manages investigator payments as per executed contract obligations, as applicable. Qualifications Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred. Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. Familiar with risk‐based monitoring approach, onsite and offsite monitoring. Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials. Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies. Demonstrate strong cross-functional collaboration skills among internal and external stakeholders. Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site. Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training. Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues. Acts with integrity in accordance with AbbVie code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment. Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html Workday Global Grade: 14

What you’ll do

The Clinical Research Associate acts as the primary point of contact for investigative sites, ensuring trial conduct, data integrity, and compliance with protocols and regulations. They also develop site engagement strategies, mentor junior staff, and proactively manage site risks to ensure study performance and patient safety.

Requirements

Candidates should have a tertiary qualification in a health-related discipline and at least one year of clinically related experience, including six months in clinical research monitoring. Strong knowledge of ICH/GCP guidelines, regulatory requirements, and the ability to work effectively in a dynamic environment are essential.

Benefits

• Innovative work culture
• Professional development
• Paid time off
• Employee stock purchase
• Wellness spending account
• Flexible health insurance
• Retirement savings programs
• Bonus plan

Listed skills

• Regulatory Compliance · Preferred
• Critical Thinking · Preferred
• Communication Skills · Preferred
• Stakeholder Management · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Clinical research monitoring
• Site engagement
• Protocol compliance
• Data integrity
• Risk-based monitoring
• Good Clinical Practices
• ICH Guidelines
• Patient recruitment
• Customer relationship management
• Stakeholder management
• Regulatory compliance
• Critical thinking
• Mentoring
• Project planning
• Communication skills
• Standard Operating Procedure
• Presentations
• Planning
• Risk Mitigation
• Leadership
• Innovation
• Workday (Software)
• Organizational Skills
• Customer Relationship Management
• Interpersonal Communications
• Risk Analysis
• Immunology
• Customer Service
• Auditing
• Cross-Functional Collaboration
• Self-Motivation
• Critical Thinking
• Time Off Management
• Active Listening
• Nursing
• Data Integrity
• Aesthetics
• Oncology
• Neuroscience
• Patient Treatment
• Clinical Research
• Patient Safety
• Clinical Trials
• Good Clinical Practices (GCP)
• Customer Centricity
• Monitoring Plan
• Facebook

Job areas

• Healthcare
• Science & Research
• Clinical Research Associate
• Biologists, Botanists, Zoologists and Related Professionals
• Clinical Research Coordinators
• Natural Sciences Managers