Clinical Research Associate (CRA) - Phase III Trials

Placements24; United States; Remote; USD 80,000 - 110,000; Full time

Job summary

Placements24 is seeking a dedicated Clinical Research Associate to oversee Phase III trials across therapeutic areas. You will be the primary liaison between sponsors and investigative sites, ensuring data integrity, compliance with GCP, and regulatory requirements.

Responsibilities include site initiation, monitoring, and close-out visits, data verification, training site staff, and ensuring timely patient enrollment while escalating site issues as needed. Travel is required.

Qualifications

• Bachelor's degree in life sciences or nursing; advanced degree preferred.
• At least 4 years as a Clinical Research Associate with Phase III exposure.
• Strong knowledge of GCP, FDA regulations, and regulatory requirements.
• Experience with CTMS and EDC systems; travel ability.

Responsibilities

• Perform site initiation, monitoring, and close-out visits to ensure protocol adherence.
• Verify data accuracy and integrity through source document verification.
• Train site staff on protocol requirements and regulatory guidelines.
• Manage sites to ensure timely patient recruitment and timelines.
• Identify, track, and resolve site-level deviations, escalating as needed.
• Prepare monitoring visit reports and contribute to progress updates.

Skills

CTMS experience

EDC systems

Communication skills

Travel readiness

Education

Bachelor's degree in life sciences or nursing or related field

Tools

CTMS

EDC systems

Job description

About the Role

Our client is seeking a dedicated and experienced Clinical Research Associate (CRA) to manage and monitor Phase III clinical trials across various therapeutic areas in the George region. In this critical role, you will be the primary liaison between the sponsor and clinical investigative sites, ensuring the integrity, accuracy, and compliance of clinical trial data. Your expertise will be vital in verifying that trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP) guidelines. This position is ideal for a detail-oriented professional passionate about advancing medical treatments through rigorous research.

Key Responsibilities

• Conduct site initiation, monitoring, and close-out visits to ensure protocol compliance and data accuracy.
• Verify the accuracy, completeness, and integrity of clinical trial data through source document verification.
• Train and provide ongoing support to investigators and study site staff on protocol requirements and regulatory guidelines.
• Manage clinical trial sites, ensuring timely patient recruitment and adherence to study timelines.
• Identify, track, and resolve site-level issues and deviations, escalating concerns as necessary.
• Prepare and present monitoring visit reports and contribute to study progress updates.

Requirements

• Bachelor's degree in a life science, nursing, or related field; an advanced degree is a plus.
• Minimum of 4 years of experience as a Clinical Research Associate , with significant exposure to Phase III trials.
• Thorough understanding of GCP guidelines , FDA regulations, and other applicable regulatory requirements.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Excellent communication, interpersonal, and organizational skills, with strong attention to detail.
• Ability to travel frequently to clinical sites within the assigned region.

Benefits

• Competitive annual salary and potential for performance bonuses.
• Comprehensive medical aid and retirement fund contributions.
• Generous travel allowance and per diem for site visits.
• Opportunities for professional growth and certification in clinical research.
• A collaborative research environment that values innovation and patient safety.