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Remote Sr Clinical Research Spec

Roseville, CA 95678

Posted: 04/04/2025 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 618867 Is job remote?: Yes Country: United States

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. 

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.? 

 

A Day in the Life 

? 

Responsibilities may include the following and other duties may be assigned. 

 
  • 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 the company 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.? 

 

Other Responsibilities: 
  • 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 

 

 

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 within the 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 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Roseville, CA

Ready to take your career to the next level? Explore job opportunities in the vibrant Roseville, California area! Nestled in the heart of Placer County, Roseville offers a perfect blend of urban amenities and natural beauty. With its proximity to Lake Tahoe and the Sierra Nevada Mountains, as well as easy access to cultural attractions like the Roseville Theatre Arts Academy and Blue Line Arts, this region provides a dynamic landscape for professionals seeking growth and inspiration. Indulge in the delicious cuisine at the family-owned restaurants on Vernon Street or catch a game at the beloved All American Speedway. Discover the charm of this bustling city and unlock endless career possibilities. Explore our job listings today and start your journey towards a fulfilling career in the captivating Roseville area!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.