Senior Clinical Research Associate

AbbVie Inc; Ciudad de México; Presencial; MXN 500,000 - 700,000; Jornada completa

Descripción de la vacante

A leading biopharmaceutical company is seeking a Clinical Research Associate to manage relationships with investigative sites. This role requires a tertiary qualification in a health-related field and a minimum of three years in clinical research, including monitoring. You will ensure the quality of clinical trials and mentor junior staff. Competitive compensation and development opportunities offered.

Formación

• Minimum 3 years of clinically related experience.
• 2 years in independent clinical research monitoring.
• Knowledge of local regulatory requirements.

Responsabilidades

• Primary Sponsor point of contact for investigative site.
• Conduct site evaluations and monitoring activities.
• Mentor and train less experienced CRAs.

Conocimientos

Communication

Interpersonal skills

Organizational skills

Critical thinking

Educación

Tertiary qualification in health-related disciplines

Descripción del empleo

Overview

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit www.abbvie.com. Follow abbVie on X, Facebook, Instagram, YouTube, LinkedIn and TikTok.

Purpose

Describe the primary goals, objectives or functions or outputs of this position.

Overview / Responsibilities

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. Advanced level of competency or experience in providing contextual information on the clinical trials, connecting stakeholders to the investigative sites and strengthening AbbVie\'s positioning. Ability to motivate and align monitoring community through leadership and mentorship.
• 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. Able to support, guide, and mentor junior personnel on Site Management activities.
• Conducts site evaluation, site training, routine on-site and off-site monitoring, 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.
• Superior understanding of site engagement and ability to customize site engagement strategy for assigned study/ies and critically apply new strategies as needed. Gather local/site insights and utilize site engagement tools to report/track progress and measure impact of that strategy.
• Superior level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Expert understanding to generate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. Develop knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
• Mentor and train less experienced CRAs on various aspects of work and provide input into their development. Support local onboarding of more junior CRAs. Demonstrate ability to listen and consider viewpoints to enhance outcomes.
• May participate in or lead global/local task forces and initiatives. Responsible for activities as assigned by manager.
• Responsible for continuous risk assessment and, in collaboration with Central Monitoring, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. Thinks critically to resolve site risk signals and implements preventative and corrective action plans to mitigate risk and promote compliance.
• Independently identifies, evaluates and recommends new/potential investigators/sites on an ongoing basis, demonstrating expert understanding and decision making.
• Ensures quality of data submitted from study sites and assures timely submission of data, including 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 contract obligations, as applicable.

Qualifications

• Appropriate tertiary qualification in health related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred.
• Minimum of 3 years of clinically related experience, of which a period of 2 years is preferable 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 appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials
• Superior knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
• Demonstrate advanced communication skills and superior cross-functional collaboration skills among internal and external stakeholders.
• Demonstrate superior planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
• Superior 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, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.
• Ability to independently use functional expertise, 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 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