Clinical Trial Specialist (Remote)

We are currently seeking a Clinical Trial Specialist to join our Neurovascular division to be based remotely in the Eastern time zone.

Who we want

•  Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities. 

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. 

• Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

What you will do

As the Clinical Trial Specialist, you will manage study start up activities for clinical trial sites, train site staff, manage Investigational Product (IP) and develop trial materials. You will establish site relationships and manage the monitoring activities of assigned clinical trials to ensure data integrity and adherence to federal regulations.

• Manage data, conduct routine site visits, ensure timely reporting of adverse events, generate, and distribute internal and external communication.

• Verify that the research site personnel, including the investigators, are conducting the study according to the clinical protocol, Good Clinical Practices, and regulatory requirements

• Ensure reporting of adverse events from research site staff to the sponsor and the IRB/IEC

• Verify data in the Case Report Forms against source documents

• Review accuracy and completeness of site records

• Verify IP accountability

• Conduct routine monitoring visits

• Prepare informed consent documents

• Completes clinical project deliverables per schedule

• Ensure audit-readiness

• Communicate relevant information to the PM/LCTS in a timely manner

• Contact sites on a consistent basis to assess study compliance

• Identify and address noncompliance issues at investigative sites

• Track Screening & Enrollment and identify issues and propose solutions

• Collect and track regulatory documents

What you need

• Bachelor’s Degree required

• 2+ years of clinical research experience as a Clinical Research Coordinator, Clinical Trial Coordinator, or Clinical Research Associate required

• Knowledge of GCP/ICH guidelines

• Knowledge of medical terminology

• Knowledge of FDA regulations and their practical implementation 

• Ability to travel extensively (50%)

$75,300 - $156,900 salary plus bonus eligible + Benefits (Health, Vision, Dental, 401K, Tuition Reimbursement, Employee Assistance Program, Wellbeing Program, Employee Stock Purchase Program). This information reflects the anticipated salary range for this position based on current national data.  Actual minimum and maximum may vary based location. Individual pay is based on skills, experience, and other relevant factors.