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SUMMARY

The Principal Investigator (PI) oversees all research projects and has overall accountability for the study. Following Good Clinical Practice (GCP) guidelines, the position will ensure that investigations are conducted according to the signed investigator statement, investigational plan, applicable regulations; for protecting the rights, safety, and welfare of subjects, and for the control of the investigational product under investigation. This position collaborates closely with Research Coordinators and Sub Investigators.

ESSENTIAL DUTIES

• Ensures the medical well-being and safety of the study participants through the safe performance and ethical execution of the clinical trials, in adherence with FDA, ICH, NIH, GCPs & HIPAA guidelines, study protocols, as well as company policies and processes.
• Overall site leadership with a focus on enhancing efficiencies, patient safety and protocol/GCP/ regulatory compliance.
• Evaluates and assesses participants to ensure only eligible participants enroll into the trials.
• Report to the sponsor adverse experiences that occur in the course of the investigation. Will read and understand the information in the IB, including the potential risks and side effects of the drug.
• Participates and engages in successful delivery and retention of study participants.
• Interacts positively and collaboratively with sponsors, clients and team members.
• Practices attention to detail in recording data and participant information, following protocol guidelines and GCPs.
• Participate in Investigator Meetings (IMs), and continuing education activities in order to maintain current knowledge of recruitment affairs and issues.
• Perform other duties as assigned, requested, or required based on the needs of the participants, protocols and/or company.

COMPETENCIES

• Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities.
• Must possess a high degree of urgency, self-motivation, integrity and dependability.
• Ability to provide outstanding patient care
• Ability to build rapport with patients and sponsors
• Ability to work independently to identify problems and implement solutions
• Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.

WORK ENVIRONMENT

• Clinical office environment
• May involve some exposure to hazards or physical risks, which require following basic safety precautions.

PHYSICAL DEMANDS

• Frequent use of keyboard and mouse
• Frequent use of computer monitors and other electronic screens
• Frequent standing, walking, bending, and stooping
• Occasional ability to lift 10 pounds

TRAVEL

• Between 5% - 10% domestic travel

EEO STATEMENT

Eastside Research Associates provides equal employment opportunities to all without regard to race, color, religion, sex (including sexual orientation or gender identity), national origin, age, disability, genetic information, or other protected status. Applicants and employees with disabilities may be entitled to reasonable accommodations under the terms of the Americans with Disabilities Act and certain state or local laws. A reasonable accommodation is an adjustment to our standard application and/or interview and/or employment process which will ensure an equal employment opportunity without imposing undue hardship on Eastside Research Associates. Please inform our team if you are requesting accommodation to complete any forms or otherwise participate in the application process or perform the essential functions of this role.

REQUIRED

• Minimum 3 years of experience in Clinical Trials Research or 10 years post training experience as a physician in general medicine or internal medicine
• Clinical skills including phlebotomy, vitals, ECGs/EKGs, IVs, etc.
• Knowledge of clinical research operations, including Good Clinical Practice guidelines
• Current Healthcare Provider BLS certification
• Excellent written and verbal communication Skills
• Experience with Microsoft Office
• High attention to detail
• Strong organizational and time management skills

PREFERRED

• Principal Investigator Experience

About Eastside Research Associates LLC

We are an emerging leader in the Greater Seattle area for sponsors who are looking for partners in their phase I-IV clinical studies. Our unique model provides us the ability to provide rapid patient enrollment, study startup and completion - without sacrificing quality.

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