Senior Clinical Research Associate

Senior Clinical Research Associate (contract)

Company Summary

SUZHOU MDCE CO., LTD is a biopharmaceuticals and medical device research and development outsourcing service company, with a primary focus on global clinical trials. Leveraging the resources and academic influence of Harvard University's global medical research, MDCE has established a comprehensive overseas service ecosystem. We provide Chinese biopharmaceutical and medical device companies with a platform-based and customized solution for international expansion. Our services encompass overseas clinical development strategy and design, overseas clinical trial management and operations, overseas product registration, and international commercialization strategy.

Since its founding in 2020, MDCE has concentrated on optimizing clinical trial designs, clinical operations, and commercialization efforts to meet global market standards. We have effectively assisted more than 40 biopharmaceutical and medical device projects to land smoothly overseas, generating a cumulative overseas profit of over 16 billion Chinese Yuan for our sponsors, enabling them to overcome the challenges of international expansion. Currently, MDCE boasts a dedicated overseas team of more than 100 professionals, collaborates with over 2,000 experts, and has partnerships with more than 100 renowned overseas hospitals. Our business network spans across regions such as the European Union, North America, Australia and New Zealand, Southeast Asia, Japan and South Korea, the Middle East, Africa, and more, with project implementations in over 40 countries.

Job Summary

It is a contract position. As a Senior CRA, you will be responsible for monitoring clinical trials and ensuring compliance with regulatory requirements, study protocols, and company policies. You will play a crucial role in the successful execution of clinical studies, contributing to the development of new therapies and medical advancements.

Key Responsibilities

1. Conduct site visits to ensure proper implementation of clinical study protocols.
2. Monitor site activities and ensure compliance with Good Clinical Practice (GCP) and regulatory requirements.
3. Review and verify clinical data for accuracy and completeness.
4. Assist in the selection and qualification of study sites.
5. Provide training and support to site staff on study protocols and procedures.
6. Collaborate with project managers and other team members to ensure timely study execution.
7. Prepare and submit monitoring reports in a timely manner.
8. Address site-related issues and escalate as necessary.
9. Maintain communication with investigators and site staff throughout the study.
10. Other tasks assigned by line manager.

Qualifications

1. Education:
Bachelor's degree in a relevant scientific discipline; advanced degree is a plus.

2. Experience:

Minimum of 8 years of experience as a Clinical Research Associate, with medical device experience.

Proven aortic stent project experience is highly desirable.

3. Skills:

Strong understanding of international and local regulations governing clinical trials.

Excellent communication and interpersonal skills.

Ability to work independently and collaboratively in a fast-paced environment.

4. Certification:
Certification as a Clinical Research Professional (CCRP) or equivalent is preferred.

5. Language:
Proficiency in Russian and English (both written and spoken)