Sr Clinical Research Spec

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)
• 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

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.

To learn more about Inclusion & Diversity at *** Click Here
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).

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 *** 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

Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile.

The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America).
Ability to travel up to 25% (domestic and international).
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.