Clinical Research Associate

JR United Kingdom; Winsford; On-site; GBP 30,000 - 50,000; Full time

Job summary

A leading company in tissue-healing technology is seeking a Clinical Research Associate to support clinical projects related to product development and compliance. The role involves managing clinical studies, ensuring regulatory compliance, and providing clinical input for product submissions. Ideal candidates will have a Bachelor's degree in a relevant field and experience with medical devices.

Qualifications

• Bachelor's degree in Natural or Health Science (e.g., PA or RN).
• Relevant clinical experience with Class II and Class III medical devices.
• Experience with clinical evaluations of new products preferred.

Responsibilities

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

Skills

Excellent communication skills

Clinical evaluations

Regulatory compliance

Data collection

Education

Bachelor's Degree in Natural or Health Science

CCRP or CCRA certification

Job description

Job Description: Clinical Research Associate (Wound Care, Adhesives and Sealants)

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 offers a wide range of surgical products including tissue adhesives, sutures, haemostats, internal fixation devices, and internal sealants, marketed under various brands. The company has a global presence with manufacturing sites and sales networks worldwide.

AMS provides equal employment opportunities and encourages diversity across its workforce.

Role Overview:

The Clinical Research Associate supports clinical projects related to Product Development (NPD), Post Market Compliance, and Clinical Evaluation, ensuring milestones and budget targets are met.

Responsibilities include:

1. Providing clinical input for product development, regulatory submissions, marketing materials, and risk documentation.
2. Managing clinical studies throughout their lifecycle, including data collection, study initiation, enrollment, and closeout.
3. Authoring Clinical Evaluations such as Clinical Evaluation Plans, Literature Searches, and Evaluation Reports.
4. Researching and implementing new methods for clinical data capture.
5. Ensuring all clinical activities comply with legislation and developing SOPs to maintain QMS.
6. Supporting clinical aspects of product submissions to regulatory authorities.
7. Participating in marketing and R&D meetings to align clinical activities with product development.
8. Providing clinical input for marketing, educational, and training programs.
9. Ensuring compliance with all regulatory standards related to clinical research and trials.
10. Promoting company values and health and safety policies.

Qualifications:

• Bachelor's Degree in Natural or Health Science (e.g., PA or RN).
• Relevant clinical experience with Class II and Class III medical devices.
• Experience with clinical evaluations of new products and Post Market Studies (preferred but not essential).
• CCRP or CCRA certification.
• Excellent communication skills.
• Willingness to travel as required.