Senior Clinical Research Associate

Integrated Resources, Inc ( IRI ); California (MO); Remote; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Senior Clinical Research Specialist to lead the development and execution of clinical studies. This exciting remote role involves overseeing clinical strategies, ensuring compliance with regulatory standards, and managing complex projects. You will play a crucial part in evaluating product safety and effectiveness while collaborating with a diverse team. If you are passionate about making a difference in the medical field and possess strong clinical research and project management skills, this opportunity is perfect for you. Join a company that values fresh ideas and diverse perspectives to drive innovation in patient care.

Qualifications

• Bachelor's degree with 4 years of clinical research experience or advanced degree with 2 years.
• Experience in clinical strategies and study design is preferred.

Responsibilities

• Lead development and execution of clinical studies to assess product safety and effectiveness.
• Manage complex clinical studies/projects and ensure compliance with regulatory standards.

Skills

Clinical Research

Project Management

Biostatistics

Regulatory Compliance

Communication Skills

Education

Bachelor’s Degree

Advanced Degree

Tools

MS Office

MS Project

Job description

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Sr Clinical Research Spec

100% remote in CA/MN

12 Months+

Preferred location(s): Santa Rosa, CA / Northern California - Bay Area / Plymouth, MN

Ability to travel up to 25% (domestic and international).

Must Have (Minimum Requirements):

To be considered for this role, the minimum requirements must be evident on your resume.

Bachelor’s degree required with a minimum of 4 years of clinical research experience (i.e., in the development and execution of clinical studies) or advanced degree with a minimum of 2 years of clinical research experience (i.e., in the development and execution of clinical studies)

Nice to Have (Preferred Qualifications):

• Degree in engineering, life sciences, or related medical/scientific field
• Clinical Research experience at *** or within a medical device industry
• Experience developing clinical strategies and study design
• Experience in Peripheral or Endovenous therapies/product
• Experience working on a global study team
• Basic understanding of biostatistics and trial design
• Experience in Research and Development (R&D)
• Ability to appropriately apply different standards related to medical devices/clinical research (SOPs, GCP, ISO, ICH, FDA, MEDDEV, MDR, etc.) as needed
• Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials
• Proficient in MS Office applications: Excel, PowerPoint, Word, MS Project (or similar scheduling software), project management techniques and tools.
• Expertise in both theoretical and practical aspects of project management
• PMP certification; Project Management Certification (preferably PMI) and/or Green Belt Certification

JOB DESCRIPTION

In this exciting role as a Senior Clinical Research Specialist (CRS) you will have primary responsibility in the development and execution of clinical studies and for developing and overseeing clinical strategies for effectively assessing performance related to the ongoing evaluation of product safety and effectiveness following market release. You will lead study management duties and drive processes to meet the milestones of complex clinical studies/projects for assigned clinical programs to evaluate performance, safety, and effectiveness of products and to satisfy applicable regulatory standards and *** internal requirements for clinical studies. Work with the Clinical Management to satisfy applicable regulatory standards and *** internal requirements for clinical studies. Assumes project management responsibilities for selected studies and site management activities as needed.

This role utilizes their broad range of experience in managing the technical execution of the trial and manages trials of a higher degree of complexity and may be global in nature. This role works independently and under only general direction. The position provides work direction and strategic oversight of personnel supporting their trial.

UNIT: Peripheral Vascular Health Operating Unit

Peripheral Vascular Health therapies are a critical part of the *** vascular portfolio, treating patients with a broad range of conditions, including Peripheral and Carotid Disease, End Stage Renal Disease, Peripheral Embolization, and Superficial and Deep Venous Disease. We lead the way in the Superficial Venous and Drug Coated Balloon markets, caring for hundreds of millions of patients globally with lifesaving and life-enhancing therapies.

We seek out and hire a diverse workforce at every level: We need fresh ideas and inclusive insights to continue to be an innovative industry leader — that’s why we make it a point to seek out, attract and develop employees who are patient-centric, passionate, and who represent the same wide variety of life experiences as our patients.

Location

Remote within the U.S; preferred location(s): Santa Rosa, CA / Northern California - Bay Area / Plymouth, MN

Ability to travel up to 25% (domestic and international).

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Other
• Industries
• Medical Equipment Manufacturing