About this role
PRIMARY FUNCTION/OBJECTIVE
To enable AbbVie’ s emergence as a world class R&D organization, the position anticipates and proactively solves study-related clinical site issues as they occur and initiates, recommends and communicates corrective action ensuring successful protocol level execution of CSM deliverables involving start-up, execution, and close-out of studies. CORE JOB 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.
Overviews 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.
PREFERRED QUALIFICATIONS
Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing) preferred.
Minimum of 1 year of clinically-related experience, of which a period of 6 months is preferable in clinical research monitoring.
Experience in on-site monitoring of investigational drug or device trials is required.
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.
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 https://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