"Alerted.org

Job Title: Principal Investigator (PI) and Sub-Investigator (Sub-I) – Clinical Research

Hours/Schedule: Full-time

Type: Contract

Overview

An established clinical research organization specializing in dermatology and other therapeutic areas is seeking experienced Principal Investigators (PIs) and Sub-Investigators (Sub-Is) to oversee and support ongoing and upcoming clinical trials onsite. These roles are key to maintaining study integrity, participant safety, and regulatory compliance while advancing scientific innovation in patient care.

Responsibilities

Principal Investigator (PI):

+ Provide overall leadership and oversight for all aspects of assigned clinical trials.

+ Ensure study conduct adheres to GCP, protocol, and regulatory standards.

+ Develop and implement study protocols while maintaining participant safety and data integrity.

+ Supervise and guide the site research team, ensuring high-quality and compliant trial execution.

+ Oversee participant recruitment, informed consent, and monitoring of adverse events.

+ Manage study budgets, investigational products, and essential documentation.

+ Serve as the main liaison between sponsors, CROs, and study personnel.

+ Ensure timely and accurate reporting of study results.

Sub-Investigator (Sub-I):

+ Support the PI in daily study operations and participant management.

+ Conduct physical exams, review medical histories, and assist with participant enrollment.

+ Obtain and document informed consent in compliance with ethical standards.

+ Monitor participant safety, document adverse events, and ensure protocol adherence.

+ Maintain accurate study data, case report forms, and clinical documentation.

+ Collaborate with study coordinators, PIs, and sponsors for consistent trial communication.

Requirements

Principal Investigator (PI):

+ M.D. or equivalent from an accredited institution.

+ Active, unrestricted medical license in the state of practice.

+ Board certification in a relevant specialty (Dermatology preferred).

+ Minimum of 5 years’ experience as a PI or Sub-I in clinical research trials.

+ In-depth knowledge of ICH-GCP, FDA, and other regulatory guidelines.

+ Proven leadership, clinical decision-making, and team management skills.

+ Strong communication and organizational abilities.

+ Commitment to ethical research and patient safety.

Sub-Investigator (Sub-I):

+ Master’s degree in Nursing (NP-certified) or Physician Assistant (PA) certification with current state licensure.

+ Minimum of 3 years’ experience in clinical research or related field.

+ Familiarity with ICH-GCP guidelines, FDA regulations, and clinical trial processes.

+ Excellent interpersonal and communication skills.

+ Proficiency with CTMS and EDC systems preferred.

+ Strong clinical judgment, attention to detail, and organizational skills.

+ Dedication to ethical conduct and patient safety.

System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

#M-

#LI-

#DI-

Ref: #568-Clinical

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.