Clinical Trial Support Specialist, International

Pulse Biosciences • International Falls, MN

5d

About The Position

The Clinical Trials Support Specialist is an essential member of the Clinical Affairs Department. This role assists with the overall conduct of clinical studies consistent with applicable regulations, guidelines, and policies in accordance with international Regulatory and Ethical guidelines for Good Clinical Practice (GCP) and International Conference on Harmonization (ICH). This position requires residence within the European Union EU.

Requirements

• Bachelor’s degree (BS/BA) or equivalent experience required.
• 3+ years of direct experience supporting multi-site clinical trials or equivalent experience in medical/scientific area.
• The ability to work in a lab/operating room environment.
• Functional knowledge of human anatomy and physiology, basic knowledge of surgery
• Knowledge of international regulations and guidelines including clinical strategy, GCPs, SOPs, submissions, product launch, labeling, product vigilance and medical device reporting.
• Strong customer orientation and site engagement skills.
• Proficient in Acrobat Adobe, Smartsheet, Microsoft Office Suite applications; and capable of learning other computer software programs including electronic data capture (EDC) and Trial Master File.
• Proficiency in English is essential, and fluency in other languages relevant to the study sites is highly desirable.
• Strong organizational, written, verbal communication and presentation skills.
• Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.
• Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast growing company.
• Ability to travel on an average of 60-85%, depending on project needs.
• Ability to lift 10-15 pounds.

Nice To Haves

• Expertise in cardiology or medical device trials is preferred.

Responsibilities

• Responsible for collecting study device and procedural data according to study protocols and regulatory guidelines at a regional/country level.
• Manage relationships with study sites, principal investigators (PIs), contract research organizations (CROs), and other study related vendors.
• Participate in pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan and applicable SOPs, to assure compliance with the protocol, country, regional and local hospital ethics committee requirements and 14155:2020.
• Ensure investigators are performing study procedures as outlined in the product’s Instructions for Use and Investigator Brochure Help with documenting adverse events and/or device deficiencies that are observed during a case in accordance with study protocols, country-specific regulatory requirements and the Monitoring Plan.
• Provides feedback as necessary to investigators both within operating room setting and outside operating room setting on the directions for use specific to the product and its maintenance.
• Takes a positive, proactive approach to solving non-complex and/or unusual clinical/therapy/technical problems Confirm subject eligibility per protocol prior to attending a case at investigator sites.
• Support device logistics, including shipments, returns, and reconciliation.
• Manage clinical supply inventory and ordering.
• Track and prepare study-specific information utilizing databases, spreadsheets, and other tools, such as Smartsheets.
• Assists with development and assembly of study binders and associated documents.
• Attend and participate in team teleconferences/meetings.

Benefits

• A variety of health insurance plans and supplemental insurance options, and 401k retirement savings plan.
• Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success.
• Enjoy paid time off, paid holidays, flexible work schedule and wellness program, including onsite gym and mindfulness classes.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees