Sr. Clinical Research Specialist

Primary Talent Partners has a 12 month contract opening for a Sr. Clinical Research Specialist to join a multinational medical device company for a remote position operating out of either Santa Rosa, CA or Plymouth, MN. 

Pay: $50.00/hr - $60.00/hr based on experience and academia 
Contract: 12 months, extensions likely, conversion possible
Type: W-2, cannot support C2C or provide visa sponsorship
Location:  Remote within the U.S; preferred location(s): Santa Rosa, CA / Northern California - Bay Area / Plymouth, MN 

Summary:
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 Medtronic internal requirements for clinical studies. Work with the Clinical Management to satisfy applicable regulatory standards and Medtronic 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. 

Operating Unit:
Peripheral Vascular Health therapies are a critical part of the Medtronic 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.

Responsibilities:

• Oversees, designs, plans, and develops clinical research studies for products that are under Clinical Investigation. 
• Prepares and authors protocols and patient record forms. 
• Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential. 
• Oversees and interpret results of clinical investigations in preparation for new device or consumer application. 
• Oversees and manages operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations 
• Prepares and manages clinical trial budgets. 
• Serves as liaison between program management and planning, study team, and leadership 
• Provides work direction to a cross-functional team which includes site managers, monitoring, safety, stats, and others 
• Reviews status of projects and budgets; manages schedules and prepares status reports. 
• Responsible for clinical supply operations, site and vendor selection. 
• People working within region/country may also have the responsibilities that include: 
• Represents Medtronic from a clinical research respective within the country / region and also collects feedback from local customers and authorities. 
• Builds and maintains optimal relationships and effective collaborations with various internal and external parties. 
• Drives local evidence dissemination & awareness.  
• Collaborates closely with medical affairs, regulatory, marketing, and other functions to gather feedback on key design elements of the trial and communicate status updates 
• Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives. 
• Develop, maintain, and continuously improve the project management process, guidelines, tools / templates, best practices, and overall implementation 

Qualifications:

• Bachelor’s degree required with a minimum of 4 years of clinical research experience (i.e., in the development and execution of clinical studies) 
• Degree in engineering, life sciences, or related medical/scientific field 
• Clinical Research experience 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) 
• Project/program management skills/experience 
• Ability to appropriately apply different standards related to medical devices/clinical research (SOPs, GCP, ISO, ICH, FDA, MEDDEV, MDR, etc.) as needed 
• Experience in Research and Development (R&D) 
• 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 
  

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com

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