MicroVention, Inc. Clinical Research Associate/Sr. CRA, Post-Market in Aliso Viejo, California

7315BR

Title:

Clinical Research Associate/Sr. CRA, Post-Market

Job Description:

INNOVATION STARTS WITH YOU

Are you interested in working for an organization that is making a difference in people’s lives every day? We’re a high-growth company, customer-focused with an entrepreneurial spirit producing some of the most reliable and technologically advanced products supported by proven clinical data. Take a closer look at what MicroVention® TERUMO has to offer.

Position Overview

  • Supports startup and execution of post-market clinical studies in line with institutional, GCP, regulatory, and compliance requirements.

  • Assists project managers in protocol development as well as in the IRB/ethics approval process and audit preparation.

  • Reviews and assists in the preparation of technical documentation including informed consents, case report forms, study tools, and study training documents.

  • Supports study project managers in budget and contract negotiations with clinical sites.

  • Coordinates and participates in study site qualification visits, site initiation visits, and the training of site staff, monitors, and vendors.

  • Facilitates communication with study site/subsite personnel, monitors, vendors, and CROs/coordinating centers.

  • Partners with study project managers to track study data, enrollment trends, and other metrics.

  • Performs other duties and responsibilities as assigned.

Auto req ID:

7315BR

Location:

Aliso Viejo, California, USA

Department Name:

650-Clinical Admin-Post Market

Qualifications:

  1. Minimum of 3 years of clinical research experience preferably in the medical device industry

  2. Strong knowledge of clinical research concepts, terminology, and regulations/guidelines such as FDA Title 21 and Good Clinical Practice (GCP).

  3. Ability to understand the clinical therapies, procedures, and devices that form the basis of the organization’s research.

  4. Outstanding detail-orientation and organizational/time management skills.

  5. Strong collaborative skills with demonstrated ability to work with site coordinators and other internal/external business partners.

  6. Proficiency in MS Office (Word, Excel, Access, PowerPoint) and Adobe Acrobat.

Desired Qualifications

  1. Experience using Electronic Data Capture systems.

  2. Bachelor’s Degree in a related field or equivalent experience (life science or engineering preferred).

  3. Experience supporting post-market clinical studies.

  4. Global and/or IDE/PMA study experience.

Additional Information

  1. The primary work locations for this position are Aliso Viejo, CA. (This is an in-house position)

  2. Candidates must be eligible to work in the U.S. and not require visa sponsorship.

  3. For more information, visit our web site at www.microvention.com

External-Facing Title:

Clinical Research Associate/Sr. CRA, Post-Market

Posting Country:

US - United States

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.