Clinical Research Associate

Clinical Research Associate (CRA)

Full time

USA- Remote

We have an exciting opportunity for a Clinical Research Associateto join Veryan Medical!

Summary

Veryan Medical is a fast-paced, rapidly growing medical device company offering a highly differentiated solution in SFA interventions. We share a commitment, a passion, and a vision for the contribution Veryan makes to innovation in interventional medicine.

Our team powers Veryan’s business. Whether sales representatives, design engineers, quality engineers, or clinical study managers, our people bring an unmatched expertise in each of their fields that both inspires and challenges.

Veryan’s culture of innovation helps each individual develop both professionally and personally, and our culture of respect means that we all work in a collaborative, empowering, and exciting environment. We are committed to excellence through our patient-centric approach, and we pride ourselves in our integrity of doing what is right and doing what we say.

Reporting to the Clinical Project Manager, the Clinical Research Associate will have the opportunity to work closely with a small international team currently working on the MIMICS-3D-USA study. This study evaluates the safety, effectiveness and performance of the BioMimics 3D Vascular Stent System. The successful candidate will be comfortable operating in a remote environment but will have travel opportunities as part of the role.

Job Requirements

Principal Responsibilities

• Support clinical trial associate assigned to studies within area of responsibility.
• Participate in the clinical site recruitment process. Perform site initiation and close-out activities.
• Preparation of study initiation documents and obtain IRB approval.
• Coordinate activities with the site and internal departments in preparation for the initiation of the study.
• Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures and provides training on completion of the eCRF.
• Perform study monitoring activities and writing monitoring reports after each monitoring visit on time.
• Serves as the primary contact with the investigators. Coordinate all correspondences with clinical sites and Veryan.
• Conducts periodic site file audits to ensure compliance with GCPs and company standard operating procedures.
• Regularly communicate with clinical sites and ensure documents in Trial Master File are up to date.
• Maintain an effective interface with Veryan’s commercial operations to ensure the interface with clinical study sites is managed professionally and is well-coordinated to build goodwill and business value.
• Other ad hoc clinical duties as required.

Education & Training

• A Bachelor’s degree in a scientific or health-related field is required.
• Strong knowledge of Clinical Research process, including working knowledge of all functional areas of clinical trials and medical terminology.

Experience & Skills

• At least 5 years of clinical study experience with minimum 2 years of independent monitoring, ideally in medical devices used in peripheral intervention.
• Advanced understanding of GCPs and ICH; and US clinical trial regulations and guidelines.
• Excellent writing skills.
• Fully proficient in the use of MS Word, Excel, PowerPoint and clinical data management systems.
• EDC system experience preferable
• Good communication, organisational skills and ability to work in a team is essential.

Company Values

• Collaborative
• Innovative
• Empowering
• Patient-centric
• Acting with Integrity

We retain your details for a period no longer than required for the application process. This allows us to process your details for the purposes of submitting, evaluating, and progressing your application, and any feedback thereafter. If you believe that any of these purposes are overridden by your interests, or fundamental rights and freedoms, please contact us at privacy@veryanmed.com.

When you initially contact us, we retain your data under Article 6(1)(a) Consent, and you have the right to request that this data is deleted. During the application period, we process your data under the legal basis of Article 6(1)(b) Performance of a Contract.

Veryan's recruitment privacy notice is available at https://www.veryanmed.com/media/7417/veryan_applicant_privacy_notice_june_2022.pdf