Senior Clinical Research Associate
RemoteAustralia
Job Summary
Act as the primary Sponsor point of contact for investigative sites, aligning and training site staff and the principal investigator on trial goals, protocol, and patient treatment principles. Conduct site evaluations, routine on-site and off-site monitoring, and closure activities in accordance with ICH/GCP guidelines, AbbVie SOPs, and quality standards. Gather local insights to customize engagement strategies, evaluate recruitment techniques, and ensure effective patient retention based on disease journey. Mentor less experienced CRAs, manage investigator payments, and audit regulatory inspection readiness at assigned sites. Proactively assess risks, resolve site risk signals, and ensure timely data submission and adverse event reporting within 24 hours. Identify and recommend potential investigators or sites for planned studies.
Required Qualifications
- Appropriate tertiary qualification in health related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing)
- Minimum of 3 years of clinically related experience
- Period of 2 years in independent clinical research monitoring of investigational drug or device trials
- Familiar with risk‐based monitoring approach
- Familiarity with onsite and offsite monitoring
- Superior knowledge on existing and emerging local regulatory and legal requirements
- Knowledge of ICH/GCP Guidelines
- Knowledge of applicable policies
- Demonstrated advanced communication skills
- Superior cross-functional collaboration skills among internal and external stakeholders
- Superior planning and organizational skills
- Ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
- Superior ability to leverage technology, tools and resources
- Superior interpersonal skills
- Excellent written, verbal, active listening and presentation skills
- Ability to establish and leverage site relationships
- Ability to independently use functional expertise
- Ability to leverage critical thinking skills
- Ability to apply good judgement to address clinical site issues
- Ability to act with integrity in accordance with AbbVie code of business conduct and leadership values
- Self-motivation
- Flexibility and Availability to participate in business meetings outside of standard hours
Desired 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
- Knowledge of appropriate therapeutic area indications
- Ability to understand and apply scientific concepts as they relate to the conduct of clinical trials
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