Senior Clinical Research Specialist

The Kestra team has over 400 years of experience in the external and internal cardiac medical device markets. The company was founded in 2014 by industry leaders inspired by the opportunity to unite modern wearable technologies with proven device therapies. Kestra’s solutions combine high quality and technical performance with a wearable design that provides the greatest regard for patient comfort and dignity. Innovating versatile new ways to deliver care, Kestra is helping patients and their care teams harmoniously monitor, manage, and protect life.

In this role, you will have responsibility for managing all aspects of Kestra sponsored clinical trials for the generation of clinical evidence for the ASSURE wearable cardioverter defibrillator (WCD) system and other portfolio products.

Requirements

ESSENTIAL DUTIES:

• Manage all aspects of the ASSURE Patient Registry study including clinical data management, analysis, reporting and abstract/manuscript preparation
• Design, plan and execute new clinical trials including investigational (IDE) studies and non-IDE studies
• Work collaboratively with clinical investigators, scientists and statisticians/analysts on the analysis, interpretation, reporting and presentation of clinical trial results
• Prepare clinical study documentation such as the protocols, case report forms, informed consent form, and training materials
• Oversee all aspects of clinical data management including electronic data capture (EDC) system and data entry
• Establish and manage working relationships with contract research organizations (CRO), clinical site investigators and research staff
• Work collaboratively with cross-functional team including marketing, clinical, regulatory and engineering in the preparation of documents for regulatory submissions to FDA or other agencies
• Negotiate site budgets and contracts
• Liaison with Institutional Review Boards (IRB)
• Setup and maintenance of trial master files
• Ensure compliance with FDA regulations, GCP and corporate SOPs
• Provide support to other functional groups requiring clinical expertise
• Adhere to Pledge of Confidentiality
• Information regarding a patient of this company shall not be released to any source outside of this company without the signed permission of the patient. Furthermore, information will only be released internally on a need-to-know basis. All Team Members will not discuss patient cases outside the office or with anyone not employed by this company unless they are directly involved with the patient’s case.

COMPETENCIES:

• Ability to be a self-starter, seek new and better methods, and work with minimum supervision
• Ability to collaborate within a Team environment and across functions
• Capability to discern relevant facts and in turn, effectively resolve issues by making good decisions (compliance, quality, integrity, ethics, and critical thinking ability)
• Ability to be flexible in a fast-paced goal-oriented environment
• Demonstrates the understanding of deadlines and time limits, ability to accomplish goals, and the desire to win

QUALIFICATIONS:

Education/Experience Required:

• Bachelor’s degree in life sciences, engineering, or related medical/scientific field
• Minimum 4 years clinical research and trial management experience
• Excellent written and verbal communication skills, interpersonal, and analytical skills
• Proficiency working with Microsoft tools (Word, Excel and PowerPoint)
• Ability to compose/edit clinical and technical documents for regulatory submissions

PREFERRED:

• Master’s degree or PhD in life sciences, engineering, or related medical/scientific field
• Knowledge of the complex clinical, regulatory and product development requirements for medical devices
• Certified Clinical Research Associate (CCRA)
• IBHRE certification or cardiac rhythm management experience (device clinic, EP lab or device company)

WORK ENVIRONMENT:

• Indoor open office environment
• Minimal noise volume typical to an office environment
• Extended hours when needed
• Kestra manufactures and provides life-saving products regulated by the Federal Food and Drug Administration and under contract with Medicare.  Kestra maintains a drug free workplace and testing is a condition of employment.

PHYSICAL DEMANDS:

• Frequent repetitive motions that may include wrists, hands and/or fingers, such as keyboard and mouse usage
• Frequent stationary position, often standing or sitting for prolonged periods of time
• Frequent computer use
• Frequent phone and other business machine use
• Occasional lifting required, up to 10 pounds

TRAVEL:

• Frequent travel, domestic and international may be required, less than 25%

OTHER DUTIES:

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the Team Member. Duties, responsibilities, and activities may change or new ones may be assigned at any time with or without notice.

Benefits

Kestra offers a very competitive benefit package including Medical, Dental, 401K with Match, etc.

Pay equity is an important part of Kestra’s Culture. Our compensation ranges are guided by national and local salary surveys and take into consideration experience level and internal equity. Each role is benchmarked based on the job description provided. If your qualifications and/or experience level are outside of the posted position, we encourage you to apply as we are growing fast and roles that are coming soon may not be posted.

Salary: $130,000-$160,000

Kestra Medical Technologies is an equal opportunity employer. Kestra Medical Technologies does not discriminate on the basis of race, color, religion, national origin, veteran status, disability, age, sexual orientation, gender identity and/or expression, marital status, or any other characteristic protected by law.

We are unable to sponsor or take over sponsorship of employment visas at this time. Applicants must be eligible to work for any employer in the U.S.

This role is an in-office position Monday - Thursday, in Kirkland, Washington with the flexibility to work from home on Fridays.