Clinical Research Associate

Advanced Medical Solutions; Winsford; On-site; GBP 30,000 - 45,000; Full time

Job summary

A leading company in innovative tissue-healing technology is seeking a Clinical Research Associate to support clinical projects for product development and compliance. This role involves managing clinical studies, ensuring regulatory compliance, and providing clinical input for marketing and R&D initiatives. Ideal candidates will have a Bachelor Degree in Natural or Health Science and relevant clinical experience with medical devices.

Qualifications

• Previous relevant clinical experience with Class II and Class III medical devices.
• Experience with new product clinical evaluations although not essential.
• Experience with Post Market Studies.

Responsibilities

• Provides clinical input for product development and regulatory submissions.
• Managing clinical studies throughout their lifecycle.
• Ensuring compliance with regulatory standards related to clinical research.

Skills

Excellent written and verbal communication skills

Clinical evaluations

Data collection

Education

Bachelor Degree in Natural or Health Science

Job description

Who are Advanced Medical Solutions?

AMS is a world-leading independent developer and manufacturer of innovative tissue-healing technology, focused on quality outcomes for patients and value for payers. AMS has a wide range of surgical products including tissue adhesives, sutures, haemostats, internal fixation devices and internal sealants, which it markets under its brands LiquiBand, RESORBA, LiquiBandFix8, LIQUIFIX, Peters Surgical, Ifabond, Vitalitec and Seal-G. AMS also supplies wound care dressings such as silver alginates, alginates, and foams through its ActivHeal brand as well as under white label. Since 2019, the Group has made seven acquisitions: Sealantis, an Israeli developer of innovative internal sealants, Biomatlante, a French developer and manufacturer of surgical biomaterials, Raleigh, a leading UK coater and converter of woundcare and bio-diagnostics materials, AFS Medical, an Austrian specialist surgical business, Connexicon, an Irish tissue adhesives specialist, Syntacoll a German specialist in collagen-based absorbable surgical implants and Peters Surgical a global provider of specialty surgical sutures, mechanical haemostasis and internal cyanoacrylate devices. AMS's products, manufactured in the UK, Germany, France, the Netherlands, Thailand, India, the Czech Republic and Israel, are sold globally via a network of multinational or regional partners and distributors, as well as via AMS's own direct sales forces in the UK, Germany, Austria, France, Poland, Benelux, India, the Czech Republic and Russia. The Group has R&D innovation hubs in the UK, Ireland, Germany, France and Israel. Established in 1991, the Group has more than 1,500 employees. For more information, please see www.admedsol.com

AMS provides equal employment opportunities for all applicants. We highly value and encourage diversity across our workforce meaning that no one will be discriminated against because of their gender, race, age, nationality, disability, or any other protected characteristic as prohibited by law.

Job Details

The Clinical Research Associate (Wound care, Adhesives and Sealants) supports the management of clinical projects, for Product Development (NPD), Post Market Compliance and Clinical Evaluation. Achieving agreed milestones and managing budget targets

What will this role involve?

Provides Clinical input for the product development process including regulatory submissions, marketing material, and risk documentation.

Managing Clinical Studies throughout their lifecycle including:

• Defining the need for data collection.
• Detailing activities with a Clinical Research Organisation (CRO) where required.
• Managing Study Initiation.
• Managing Study enrolment phase.
• Managing Study Close out.

Authoring Clinical Evaluations including:

• Clinical Evaluation Plan.
• Clinical Literature Search.
• Clinical Evaluation Report.
• Researching and defining new methods for Clinical Data capture.
• Ensuring all Clinical activities are carried out in line with local and international legislation.
• Developing Standard Operation Procedures to help maintain an established QMS.
• Supporting, on time, Clinical aspects of Product submissions to Regulatory Authorities.
• Participating in Marketing and R&D project team meetings as needed so that clinical activities support product development projects.
• Supporting Marketing and other departments with clinical input for preparation of symposia, trade/medical shows, educational and training programs.
• Ensuring compliance with all applicable regulatory standards related to clinical research, clinical trials, interactions with physicians, clinical policies, guidelines and regulations.
• Promoting and demonstrate Care, Fair and Dare values in the workplace.
• Promoting health and safety policies in the workplace.

What we're looking for?

• Bachelor Degree in Natural or Health Science (PA or RN).
• Previous relevant clinical experience with Class II and Class III medical devices.
• Experience with new product clinical evaluations although not essential.
• Experience with Post Market Studies.
• CCRP or CCRA.
• Excellent written and verbal communication skills.
• Job Holder should be prepared to travel when required.