AbbVie Clinical Research Associate I responsible for site engagement and monitoring to ensure compliance and data integrity in clinical trials. Supports site staff and investigators under supervision to drive study performance.
Responsibilities
Considered as the primary point of contact for the investigative site, provides contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie’s positioning.
Aligns, trains and motivates the site staff and principal investigator under supervision on the goals of the clinical trial program, protocol, and patient treatment principles for the trial ensuring a trusted partnership.
Conducts site evaluation, site training, routine, and site closure monitoring activities under supervision, in compliance to the protocol and monitoring plans and accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to quality standards in conducting clinical research, ensuring safety and protection of study subjects.
Customize site engagement strategy for assigned study(ies) under supervision. Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.
Fundamental level of competency connecting 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 disease journey.
Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. Ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution.
Ensures 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 under supervision and support from more experienced CRAs.
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 audit and regulatory inspection readiness at assigned clinical site at all times.
Manages investigator payments as per executed contract obligations, as applicable.
