Clinical Research Associate (Remote)

Placements24; Gqeberha; Hybrid; ZAR 550.000 - 900.000; Vollzeit

Benefits dieser Stelle

Health insurance

Retirement contributions

Generous paid time off

Zusammenfassung

Placements24 is seeking a highly organized Clinical Research Associate for a fully remote role in South Africa. You will monitor clinical trial sites, ensure protocol and regulatory adherence, and support data integrity from a home office.

The ideal candidate holds a life science degree, 3+ years CRA experience, and proficiency with CTMS/EDC; strong communication and the ability to work independently are essential. Travel 40-60% may be required where applicable.

Qualifikationen

• Bachelor’s degree in life science or related field.
• Minimum 3 years as a CRA with monitoring experience.
• Strong understanding of clinical trial processes and ICH-GCP.
• Excellent organizational and time management skills.
• Ability to work independently with minimal supervision and remote workload.
• Willingness to travel 40-60% if applicable.

Aufgaben

• Conduct site initiation, monitoring, and close-out visits.
• Ensure compliance with protocols, FDA regulations, ICH-GCP guidelines.
• Verify data accuracy by reviewing CRFs and source data.
• Maintain communication with investigators and site staff.
• Identify, document, and resolve site-level issues and deviations.
• Train site personnel on study procedures and regulatory requirements.
• Oversee drug accountability and proper storage of investigational products.
• Prepare monitoring reports and follow-up on action items.
• Ensure timely query resolution and data clarification with data management.
• Maintain regulatory binders and current essential documents.

Kenntnisse

Organizational skills

Communication

Time management

Problem-solving

Independent work

English proficiency

Ausbildung

Bachelor's degree in life science

Tools

CTMS

EDC systems

eSDV

Jobbeschreibung

About the Role

Our client, a dynamic and forward-thinking pharmaceutical research organization, is seeking a highly organized and motivated Clinical Research Associate (CRA) to join their expanding team. This is a fully remote position, allowing you to contribute to critical clinical trials from the comfort of your home office, potentially located anywhere in South Africa, though initial onboarding may involve limited travel. You will be responsible for monitoring clinical trial sites, ensuring adherence to protocols, regulations, and Good Clinical Practice (GCP) guidelines. This role is pivotal in ensuring the integrity and quality of data collected during clinical studies, contributing directly to the development of new and innovative medicines. If you are a detail-oriented professional with a passion for clinical research and possess excellent communication skills, this remote opportunity is ideal.

Key Responsibilities

• Conduct site initiation, routine monitoring, and close-out visits for clinical trial sites.
• Ensure compliance with study protocols, FDA regulations, ICH-GCP guidelines, and other applicable regulations.
• Verify the accuracy, completeness, and validity of clinical data by reviewing source documents and case report forms (CRFs).
• Manage and maintain effective communication with clinical investigators and site staff.
• Identify, document, and resolve site-level issues and deviations.
• Train site personnel on study procedures, data collection, and regulatory requirements.
• Oversee drug accountability and ensure proper storage and handling of investigational products.
• Prepare monitoring reports and follow up on action items.
• Ensure timely query resolution and data clarification with the data management team.
• Maintain regulatory binders and ensure all essential documents are current and accurate.

Requirements

• Bachelor's degree in a life science, nursing, or a related healthcare field.
• Minimum of 3 years of experience as a Clinical Research Associate, preferably with monitoring experience.
• Strong understanding of clinical trial processes, ICH-GCP guidelines, and regulatory requirements.
• Excellent organizational and time management skills.
• Proficient in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Strong communication, interpersonal, and problem-solving abilities.
• Ability to work independently with minimal supervision and manage a remote workload effectively.
• Willingness to travel to clinical sites as required (estimated 40-60% travel, if applicable to the role structure, though this is a remote-first position).
• Proficiency in English, both written and verbal.
• Experience with electronic source data verification (eSDV) is a plus.

Benefits

Our client offers a highly competitive salary and a comprehensive benefits package, including health insurance, retirement contributions, and generous paid time off. As a fully remote position, this role provides exceptional flexibility and work-life balance. Opportunities for professional development and career advancement within a growing organization are readily available. Our client invests in their employees' growth and provides access to continuous learning resources and training programs. This role based out of Port Elizabeth offers the unique advantage of being fully remote, removing geographical constraints. We are committed to fostering an inclusive and innovative work culture.