Research Analyst

• Considered as the primary point of contact for the investigative site.
• High level of competency or experience in providing 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 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 with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.
• Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies).
• 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.
• Advanced 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.
• Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development.
• May participate in global/local task forces and initiatives.
• Responsible for activities as assigned by manager.
• 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.
• Advanced 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 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.
• 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.

Clinical Research Associate II

• Monitor on-site and remotely clinical trials in accordance with TFS and/or sponsor Standard Operating Procedures GCP and ICH guidelines and applicable regulatory regulations
• Perform all required monitoring activities at the study sites to assess and ensure subjects safety, data integrity and quality
• Verify the protection of study participants by informed consent procedures and protocol requirements that follow appropriate regulations
• Review CRFs (electronic or paper) and subject source documentation for validity and accuracy
• Verify proper management and accountability of Investigational Product
• Timely reporting of actions taken during monitoring visits in Monitoring Visit Report including findings, corrective and preventive actions already taken and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate
• Providing site with the listing of issues identified during monitoring visit and action items which will need to be addressed in a timely manner
• Timely delivering site documents to eTMF or paper TMF
• Verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and ICH guidelines and local regulatory requirements

Senior Clinical Research Associate

• Ensure a regular and reliable on-site presence, maintaining punctuality and availability to support daily operations.
• Follow established work instructions, Standard Operating Procedures (SOPs) and company policies.
• Perform assigned tasks accurately and within set deadlines, supporting operational activities and process updates.
• Maintain clear and timely communication with colleagues and your supervisor regarding task status and any issues or delays.
• Conduct all activities in compliance with applicable SOPs, Good Manufacturing Practices (GMP) and regulatory requirements (e.g., FDA).
• Support effective handling, organization and traceability of samples throughout their lifecycle.

Associate, Analytical Research

• Conduct and report all types of onsite monitoring visits across sites in Portugal
• Be involved in study startup
• Perform CRF review, source document verification and query resolution
• Be responsible for site communication and management
• Be a point of contact for in-house support services and vendors
• Communicate with internal project teams regarding study progress
• Be involved in site identification process
• Support regulatory team in preparing documents for study submissions
• Prepare for and participate in audits and inspections

Research Analyst jobs in Portugal

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Clinical Research Associate II

Senior Clinical Research Associate

Associate, Analytical Research

Clinical Research Associate II