Senior Clinical Research Associate

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 around 10,000 colleagues, we provide our products and services in almost 100 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. Group revenues in 2022 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com
At Convatec we’re transforming our business for the better. Better products. Better ways of working. And better ways of delivering for our customers and each other. We’re aiming for nothing short of excellence. Join us as a Senior Clinical Research Associate and you’ll do the same.

 

Summary

The Senior Clinical Research Associate (Sr. CRA) provides operational expertise and leadership to ensure the effective and efficient delivery of clinical site monitoring across all Convatec’s clinical studies. The Sr. CRA is the key representative for our Site Management team, and they provide leadership and direction to Clinical Research Associates (CRAs) throughout the lifecycle of a study.  The Sr. CRA assesses clinical study site performance, adequacy of monitoring activities, reviews monitoring visit reports and metrics, and proactively identifies and communicates site management and monitoring issues and risks to the Convatec Clinical Study Manager. The Sr. CRA ensures the monitoring activities of their assigned study(s) are in accordance with Convatec’s policies and procedures, ISO and local regulations. The Sr. CRA will report directly to the Head, Global Clinical Operations.

This is a remote role but seeking someone located in the Eastern time zone.

Key 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 key 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 independently customising and maintaining the Monitoring Plan, Issues and Visit Report writing guidance, Project Specific Training material, Project Specific Training Logs.
• Implementation of enrolment and recruitment strategies.
• Production and present 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.
• Host routine CRA team calls with a focus on best practice / knowledge sharing.
• 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