Senior Clinical Research Associate

AbbVie

16h

About The Position

AbbVie is seeking a driven and detail-oriented Senior Clinical Research Associate to join our world-class clinical development team, where you will play a pivotal role in advancing life-changing therapies by overseeing and monitoring clinical trial sites to ensure the highest standards of quality, compliance, and patient safety. The ideal candidate brings a strong foundation in ICH/GCP guidelines, proven site management expertise, and the collaborative spirit to thrive in a fast-paced, science-driven environment dedicated to making a remarkable impact on patients' lives.

Requirements

• 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.
• 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

Nice To Haves

• Experience in Early Phase 1 and First-in-Human healthy volunteer studies highly desirable.
• Knowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials

Responsibilities

• Act as the primary Sponsor point of contact for the investigative site, providing contextual information on the clinical trials, connecting stakeholders to the investigative sites and strengthening 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.
• Conduct site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance, 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.
• Gather local/site insights and utilise site engagement tools to report/track progress and measure impact of that strategy.
• Connect 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’s disease journey.
• Develop solid 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 provides input into their development.
• Responsible for activities assigned by manager and participate in global/local task forces and initiatives.
• Proactively responsible for continuous risk-assessment, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
• Resolves site risk signals while having a robust understanding of site processes to drive study execution, ensuring 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 ongoing basis 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.
• Audit and regulatory inspection readiness at always assigned clinical site.
• Manages investigator payments as per executed contract obligations, as applicable.
• Report any adverse event within 24 hours as per AbbVie’s policies and procedures.
• Proactively participate in AbbVie’s WHS programs, adhere to policies and promote a safe work environment at all times.
• Adhere to AbbVie’s codes of conduct and compliance processes, including timely training and maintaining ethics and integrity.
• Other ad hoc duties such as administrative duties, as requested.

Benefits

• inclusive, flexible, and supportive workplace that values and respects every individual
• operating with integrity, driving innovation, transforming lives, and embracing diversity and inclusion
• fair and inclusive recruitment process without discrimination
• flexible and accessible hiring process

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree