Remote Lead CRA — Mentorship & Global Oversight

PSI CRO; United States; On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Stability of a privately held CRO

Leadership-focused CRA role with low/f

Mentorship opportunities

Career development opportunities

People-first culture

Global organization

Job summary

PSI CRO is seeking a Lead Clinical Research Associate in the United States to provide leadership, oversight, and mentorship across regional clinical trials with minimal site assignments and a low-travel model focused on remote oversight and high-quality study execution.

The role emphasizes leadership, mentorship, and consistency in monitoring practices, with collaboration across Project Managers, regional leads, and cross-functional teams to ensure studies run smoothly and safely.

Qualifications

• MD, MPharm, RN or Life Sciences degree.
• Minimum of 4 years' site monitoring experience with leadership on global clinical projects.
• Experience with monitoring visits in Phase II and/or III.
• Oncology experience preferred.
• Experience in Radiation Therapy or Radiopharmaceuticals, CAR-T Therapy or other advanced therapies preferred.
• GI conditions experience preferred.
• Full working proficiency in English.
• Proficiency in MS Office applications.
• Ability to travel.
• Valid driver’s license (if applicable).

Responsibilities

• Monitors project timelines, patient enrollment, data cleaning, and ensures corrective/preventive actions.
• Reviews monitoring visit reports and ensures reporting compliance of the monitors.
• Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and Project Manager.
• Leads country-level project team calls and provides status updates to Regional Lead/Project Manager.
• Provides project-specific training and prepares training materials under supervision.
• Supervises source data verification and follows up on data queries at site level.
• Ensures proper handling, use, accountability, reconciliation, and return of all investigational products and study supplies.
• Reviews essential study documents and supervises ISF/TMF reconciliation at site and regional level.
• Ensures data integrity and compliance at a site level.
• Collaborates on investigator/site feasibility and study startup.
• Manages monitors in query resolution and central monitoring observations.
• Coordinates safety information flow and deviation reporting.

Skills

English proficiency

Planning & multitasking

Communication skills

Travel ability

Driver's license

Education

MD, MPharm, RN or Life Sciences degree

Tools

MS Office

Job description

PSI CRO is seeking a Lead Clinical Research Associate in the United States to provide leadership, oversight, and mentorship across regional clinical trials with minimal site assignments and a low-travel model focused on remote oversight and high-quality study execution.

The role emphasizes leadership, mentorship, and consistency in monitoring practices, with collaboration across Project Managers, regional leads, and cross-functional teams to ensure studies run smoothly and safely.