Clinical Research Associate 2 at AbbVie United States

About the Position

Clinical Research Associate 2 Job at AbbVie, United States

AbbVie is hiring a Clinical Research Associate 2 to monitor clinical trial activities and ensure compliance with regulations and quality standards.

Responsibilities

• 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 to 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, and AbbVie Standard Operating Procedures (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. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.

Requirements

• Appropriate tertiary qualification, health-related (e.g., Medical, Scientific, Nursing) preferred.
• Minimum of 2 years of clinically related experience, including at least 1 year of independent monitoring experience. Preference will be given to candidates with experience independently conducting each type of monitoring visit.
• Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
• Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines, and applicable regulations.
• Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. Ability to work, understand, and follow work processes within the assigned function.
• Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity. Ability to address study-related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated. Ability to use functional expertise and exercise good judgment.
• Demonstrated business ethics and integrity.

We Offer

• Competitive salary
• Full-time employment
• Opportunity to work with a leading biopharmaceutical company

About the Company

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.

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