Lead Clinical Trials Investigator

Green Key Resources; Ridgewood (NJ); On-site; USD 180,000 - 240,000; Full time

Job summary

Green Key Resources is seeking a Clinical Research Physician Investigator (PI) to oversee and conduct clinical trials in line with FDA regulations and GCP guidelines. The PI will ensure that all delegated tasks are performed by qualified personnel and that the rights and welfare of participants are protected.

The role includes reviewing study protocols, overseeing investigators, coordinating subject screenings, recruitment, and data integrity, with on-site responsibilities in a clinical/lab

Qualifications

• Must conduct or supervise clinical research per FDA 21 CFR Part 312 and FDA Form 1572.
• Adhere to FDA regulations, GCP, SOPs and IRB plans.
• Maintain confidentiality of sponsor and trial data.

Responsibilities

• Review study-related activities and protocols.
• Assume Investigator responsibilities per regulatory guidelines.
• Adhere to study protocols and regulatory requirements at all times.
• Maintain study sponsor and trial confidentiality.
• Perform procedures such as physical exams, informed consent, subject history, adverse events, data collection and coordination of visits.
• Assist in study monitor visits preparation.
• Screen and recruit subjects.
• Provide weekend and after-hours coverage.
• Oversee Sub-Investigators and recruitment team.

Skills

Bilingual English/Spanish

Written & verbal communication

Organizational skills

Attention to detail

People skills

Flexibility

Diplomatic & professional comunic

Interpersonal skills

Mathematical knowledge

Microsoft Office

Tools

Microsoft Office

Job description

Green Key Resources is seeking a Clinical Research Physician Investigator (PI) to oversee and conduct clinical trials in line with FDA regulations and GCP guidelines. The PI will ensure that all delegated tasks are performed by qualified personnel and that the rights and welfare of participants are protected.

The role includes reviewing study protocols, overseeing investigators, coordinating subject screenings, recruitment, and data integrity, with on-site responsibilities in a clinical/lab