Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging advanced capabilities to drive industry leading performance. Partners with study teams, AbbVie internal R&D; stakeholders, investigators, and site staff for meaningful and effective engagements positioning AbbVie as the partner of 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 - Primary sponsor point of contact for the investigative site; provide contextual information on clinical trials, connect stakeholders to investigative sites, and strengthen AbbVie positioning. Motivate and align monitoring community through leadership and mentorship.

- Aligns, trains and motivates site staff and principal investigator on the goals of the clinical trial program, protocol, and patient treatment principles, ensuring a trusted partnership. Supports, guides, and mentors junior personnel on site management activities.
- Conduct site evaluation, training, routine on‑site and off‑site monitoring, and site closure monitoring activities with compliance to protocol, monitoring plans, GCPs, ICH Guidelines, AbbVie SOPs, and quality standards, ensuring safety and protection of study subjects.
- Customize site engagement strategy for assigned studies, collect local/site insights, and use engagement tools to report and track progress and measure impact.
- Translate study protocol, scientific principles and clinical trial requirements into day‑to‑day execution activities; create effective recruitment and retention plans based on the patient disease journey. Knowledge of therapeutic area, asset and clinical landscape,



and patient journey to enable successful recruitment and protocol compliance.
- Mentor and train less experienced CRAs on various aspects of work and provide input into their development. Support local onboarding of junior CRAs and actively listen to viewpoints to enhance outcomes.
- Participate or lead in integral/local task forces and initiatives; responsible for activities assigned by manager.
- Perform continuous risk assessment proactively; collaborate with Central Monitoring team to detect early study performance or safety issues. Resolve site risk signals and ensure preventative and corrective action plans are implemented.
- Identify, evaluate and recommend new/potential investigators or sites on an ongoing basis; use networking or internal AbbVie requests to place planned clinical studies with qualified investigators.
- Ensure quality of data submitted from study sites, timely data submission, appropriate reporting and follow‑up for all safety events, audit and regulatory inspection readiness, and manage investigator payments per contract obligations.

Qualifications - Appropriate tertiary qualification in health‑related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred.

- Minimum of 3 years of clinically related experience, including at least 2 years in independent clinical research monitoring of investigational drug or device trials in any therapeutic area.



Familiar with risk‑based monitoring approach, onsite and offsite monitoring.
- Knowledge of therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
- Superior knowledge of current and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
- Excellent communication skills and superior cross‑functional collaboration skills among internal and external stakeholders.
- Strong planning and organizational skills and 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 the health of the site.
- Superior interpersonal skills with excellent written, verbal, active listening and presentation skills, and ability to establish and leverage site relationships and trusted partnerships.
- Ability to use functional expertise, critical thinking and good judgement to address clinical site issues independently.
- 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.

Equal Opportunity 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 – for more information, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html. US & Puerto Rico applicants seeking a reasonable accommodation, visit https://www.abbvie.com/join-us/reasonable-accommodations.html.

📌 Senior Clinical Research Associate (Puerto Madryn)
🏢 Abbvie
📍 Puerto Madryn