Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com

 

About the role

The Clinical Research Associate (CRA) ensures the effective and efficient delivery of clinical site monitoring across assigned Convatec clinical studies. The CRA assesses clinical study site performance, adequacy of monitoring activities, and proactively identifies and communicates monitoring issues and risks to the Convatec Clinical Study Manager. The CRA ensures the monitoring activities of their assigned study(s) are in accordance with Convatec’s policies and procedures, ISO and local regulations.

Key duties and responsibilities

• Ensuring overall project efficiency and adherence to project timelines; report metrics and out-of-scope activities to the Clinical Study Managers, and Head Global Clinical Operations as required.
• Working closely with other functional groups within Convatec’s Clinical Operations team such as data management, clinical study management, quality assurance and biostatistics where necessary to support milestone achievement and to manage study issues and obstacles.
• Manage 3rd party clinical monitoring Vendors where necessary to support milestone achievement and to manage study issues and obstacles.
• Build and develop relationships with clinical study sites.
• Manage and follow study activities through ongoing tracking and review of study progress. Provide input and report progress to the assigned clinical study management leaders.
• Conducts monitoring visits (site qualification visit, site initiation visit, interim monitoring visit, or close-out visit), and co-monitoring visits, as required by study needs.
• Responsible for adhering to the Monitoring Plan, , Project Specific Training material, Project Specific Training Logs.
• Implementation of enrollment and recruitment strategies.
• Assist in training, including Site Initiation Visit presentation, to healthcare professionals, colleagues, and other professionals, as required.
• Reviews monitoring visit reports and metrics, including protocol deviations and follow-up items, to evaluate for compliance and trends, summarizing for the study team, escalating issues, and involved in the development of corrective and preventative actions, as needed.
• Responsible for reviewing clinical data (e.g. electronic case report forms, central laboratory data, risk-based monitoring outputs, etc.), provide Central Data Review and coordinate Risk Based Monitoring strategy, as applicable.
• Handle escalations for site management questions and issues for assigned projects.
• Responsible for ensuring sites are inspection ready, including the Investigator Site File (ISF), for health authority inspections at all times.
• Supports audit and inspection activities as needed and may assist with on-site CRA training and evaluation upon request.
• Works with Clinical Operations management on developing and updating best practices and processes and SOPS, with input on discussions around quality by design and operational delivery.
• Clear and sustained demonstration of Convatec's core values.
• May be assigned additional responsibilities as needed to support projects and other corporate/departmental initiatives.

Skills & Experience

• Strong attention to detail.
• Excellent collaborative team player.
• Medical Device experience strongly preferred.
• Comprehensive understanding on how to properly assess an investigative site's capabilities for conducting clinical research. Knowledge of how to select and qualify an investigative site.
• Ability to monitor and report on the progress of a clinical study from start-up to completion.
• Experience in the conduct of site evaluation, initiation, interim, and close-out visits.
• Knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs).
• Understanding of monitoring requirements in LATAM is a plus.
• Fluent verbal and written English essential.
• Experience working with Veeva is a plus.
• Experience in wound care is a plus.
• Willi