Clinical Research Associate II
Location
Serbia
Posted
7 days ago
Salary
0
Seniority
Mid Level
Job Description
Clinical Research Associate II
AbbVie
• Anticipates and proactively solves study-related clinical site issues as they occur and initiates, recommends, and communicates corrective action to ensure successful protocol-level execution of Clinical Operations deliverables involving start-up, execution, and close-out of studies. • Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. • Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and quality standards in conducting clinical research. • Conducts site qualification, initiation, interim monitoring, and study closeout visits for Phase 1–4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie SOPs, and business processes. • Oversees the overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives. • Proactively manages the site and ensures action plans are put into place as needed to ensure compliance. • Ensures regulatory inspection readiness at assigned clinical sites. • 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 safety and protection of study subjects through compliance with the study monitoring plan, AbbVie SOPs, ICH Guidelines, and applicable regulations. • Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members. • Manages investigator payments as per executed contract obligations. • Negotiates investigator/hospital agreements with stakeholders. • Maintains and completes own expense reports as per local and applicable guidelines. • Identifies, evaluates, and recommends new/potential investigators/sites on an ongoing basis.
Job Requirements
- 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.
Benefits
- AbbVie is an equal opportunity employer
- Operating with integrity, driving innovation, transforming lives and serving our community.
- Equal Opportunity Employer/Veterans/Disabled.
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