Senior Clinical Research Associate, Global Trials Lead

Openkrill; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

ProTrials is seeking a Contract Senior Clinical Research Associate to join our team. The Contract Sr CRA plays an integral part in the successful monitoring and management of clinical trials, ensuring trials are conducted, recorded, and reported in accordance with the protocol, SOPs, ICH GCP, and all regulatory requirements.

Contract Sr CRAs may travel up to 65%. The role involves monitoring site visits, training site personnel, managing supplies, data review, regulatory support, and maintaining

Qualifications

• RN or Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience.
• Detail-oriented and organized.
• Excellent interpersonal and communication skills; strong problem-solving abilities.

Responsibilities

• Monitor and manage clinical trials at qualified sites across initiation, visits, and close-out.
• Train site personnel on protocols, source documentation, and case report forms.
• Coordinate supply preparation and return at sites.
• Monitor product dispensing, inventory, and reconciliation.
• Oversee laboratory sample storage and shipment.
• Review site enrollment, visits, protocol deviations, SAEs and labs.
• Review data queries and resolutions with study centers.
• Review regulatory documents for accuracy and assist with issues.
• Maintain complete study files and on-site documentation.
• Maintain timely contact with study centers, investigators, and coordinators.
• Support CRA I/II staff with solutions to issues.
• Ensure data integrity and compliance with SOPs and regulations.

Skills

Detail-oriented

Organizational skills

Interpersonal skills

Communication skills

Problem-solving skills

Adaptability

Multitasking

Education

RN or Bachelor or advanced degree in biological sciences or related field

Job description

ProTrials is seeking a Contract Senior Clinical Research Associate to join our team. The Contract Sr CRA plays an integral part in the successful monitoring and management of clinical trials, ensuring trials are conducted, recorded, and reported in accordance with the protocol, SOPs, ICH GCP, and all regulatory requirements.

Contract Sr CRAs may travel up to 65%. The role involves monitoring site visits, training site personnel, managing supplies, data review, regulatory support, and maintaining