Senior Clinical Research Associate (CRA) - Remote

Placements24; Klerksdorp; Ibrido; ZAR 600.000 - 900.000; Tempo pieno

Vantaggi offerti da questo lavoro

Remote work

Medical/dental/vision insurance

Online training resources

Descrizione del lavoro

Placements24 client, a global CRO, is seeking a Senior Clinical Research Associate to join a fully remote team. You will oversee site selection, initiation, monitoring, and close-out activities across therapeutic areas, ensuring GCP/ICH compliance and proper regulatory submissions.

Travel to sites may be required occasionally. Candidates should hold a Life Sciences degree and have at least 5 years of CRA experience in pharma or CRO settings, with strong communication skills and proficiency in

Competenze

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related healthcare field.
• Knowledge of GCP/ICH-GCP guidelines and regulatory requirements.
• Experience monitoring clinical trials across phases and therapeutic areas.

Mansioni

• Oversee site selection, initiation, monitoring, and close-out visits.
• Ensure protocol and regulatory compliance, data integrity, and patient safety.
• Manage documentation,AE/SAE reporting, and site staff training.
• Coordinate with sponsor, sites, and internal teams; track budgets and timelines.

Conoscenze

GCP/ICH-GCP knowledge

Site monitoring

Regulatory submissions

Communication skills

Travel readiness

Formazione

Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related healthcare field

Strumenti

EDC systems

CTMS

Descrizione del lavoro

About the Role

Our client, a rapidly expanding global Contract Research Organization (CRO) specializing in clinical trials within the pharmaceutical and biotechnology sectors, is seeking an experienced Senior Clinical Research Associate (CRA) to join their fully remote team. This pivotal role involves overseeing and managing the conduct of clinical trials across various therapeutic areas, ensuring compliance with Good Clinical Practice (GCP), regulatory requirements, and study protocols. As a remote CRA, you will be responsible for site selection, initiation, monitoring, and close-out activities, acting as the primary liaison between investigational sites and the sponsor. This position requires exceptional organizational skills, a proactive approach to problem-solving, and the ability to foster strong relationships with investigators and site staff. This is a fantastic opportunity to advance your career in clinical research within a flexible, remote-first environment, contributing to the development of life-saving therapies without the need for a fixed office location.

Key Responsibilities

• Conduct site selection visits, qualification visits, and site initiation visits to ensure sites are prepared for study conduct.
• Perform routine monitoring visits (on-site or remote) to verify data accuracy, protocol compliance, and patient safety.
• Ensure all investigational site personnel are adequately trained on the study protocol and applicable regulations.
• Manage investigational product accountability and reconciliation at study sites.
• Oversee the timely submission and quality of study-related documentation.
• Identify and report adverse events (AEs) and serious adverse events (SAEs) according to protocol and regulatory requirements.
• Facilitate communication between study sites, the sponsor, and internal project teams.
• Prepare site monitoring reports and participate in team meetings.
• Ensure adherence to study budgets and timelines, proactively identifying and resolving site-level issues.
• Close-out study sites upon completion of all study-related activities.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field.
• Minimum of 5 years of progressive experience as a Clinical Research Associate in a pharmaceutical or CRO setting.
• In-depth knowledge of GCP guidelines, ICH-GCP, and relevant regulatory requirements (e.g., FDA, EMA, SAHPRA).
• Proven experience in monitoring clinical trials across different phases and therapeutic areas.
• Excellent understanding of clinical trial processes, documentation, and regulatory submissions.
• Strong interpersonal, communication, and presentation skills.
• Proficiency in using electronic data capture (EDC) systems, clinical trial management systems (CTMS), and other relevant software.
• Ability to work independently, manage time effectively, and travel as required (though this role is remote, occasional travel might be necessary for specific sites).
• Demonstrated ability to build rapport and maintain effective working relationships with clinical site staff.
• Problem-solving skills and a proactive approach to identifying and resolving site-level challenges.

Benefits

This fully **remote** position offers a highly competitive salary and benefits package, including comprehensive medical, dental, and vision insurance, a generous retirement savings plan, and performance-based bonuses. Our client is committed to employee well-being and professional growth, providing access to extensive online training resources and opportunities for career advancement within a global organization. This role allows for significant work-life balance and the flexibility to work from anywhere within **South Africa**. You will be part of a collaborative and supportive team culture focused on delivering high-quality clinical trial services.