Lead 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. Last year, group revenues 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 Lead Clinical Research Associate and you’ll do the same.

The Lead Clinical Research Associate (LCRA) provides operational expertise and leadership to ensure the effective and efficient delivery of clinical site monitoring across all Convatec’s clinical studies. The LCRA 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 LCRA 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 LCRA ensures the monitoring activities of their assigned study(s) are in accordance with Convatec’s policies and procedures, ISO and local regulations. The LCRA will report directly to the Head, Global Clinical Operations.

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.

Conduct monitoring visits (site qualification visit, site initiation visit, interim monitoring visit, or close-out visit), and co-monitoring visits, as required.

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 projects.

Host routine CRA team calls with 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 and operational delivery.

Provide on boarding and line management of junior CRAs as required.

Travel Requirements up to 25%.

#LI-TG1

#Hybrid

Education

Bachelor’s or equivalent degree required, preferably in life sciences, medicine, or related discipline.

Minimum of 5 years Clinical Research experience, preferably some within the medical device arena, with at least 3 years of experience in clinical site monitoring. Years of experience may be considered in lieu of education.

Prior team and/or site lead experience is preferred.

Key Skills:

Strong attention to detail.

Excellent collaborative team player

Medical Device experience strongly preferred.

Comprehensive understanding of how to properly assess an investigative sites capabilities for conducting clinical research. Knowledge of how to select and qualify an investigative site.

Ability to monitor and report on clinical study progress, start-up to completion.

Extensive experience conducting site evaluations, initiation, interim, and close-out visits.

Advanced Knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs).

Understanding of monitoring requirements in LATAM preferred

Fluent verbal and written English essential; multilingual (Spanish) a plus.

Willingness to travel domestically with some International as well.

Beware of scams online or from individuals claiming to represent Convatec

A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.

If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at careers@Convatec.com .

Equal opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives

Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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