Remote Clinical Research Associate - Pharmaceutical Trials

Placements24; George; Híbrido; ZAR 600 000 - 900 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health insurance

Retirement savings plan

Paid time off

Resumo da oferta

Placements24 is seeking an experienced Clinical Research Associate for a fully remote position. You will monitor clinical trial sites, verify SDV data, and ensure GCP compliance across protocols.

The role requires strong communication with investigators and site staff and occasional travel for essential visits. The ideal candidate has a life sciences degree (Master's preferred), 3+ years in a CRA role, and solid CTMS/EDC experience.

Qualificações

• Experience in monitoring clinical trials and ensuring data integrity.
• Strong understanding of GCP/ICH and regulatory requirements.
• Proven ability to work independently in a remote setup.

Responsabilidades

• Conduct site initiation, interim monitoring, and site closure visits.
• Verify data accuracy via SDV and ensure protocol compliance.
• Maintain relationships with investigators and site staff; provide training as needed.
• Monitor recruitment and retention at sites and report findings.
• Prepare monitoring visit reports and escalate issues as needed.
• Identify and report adverse events per procedures.
• Contribute to study documents and monitoring plans.

Conhecimentos

Site monitoring

GCP compliance

CTMS/EDC experience

Communication

Remote work

Formação académica

Bachelor's degree in life sciences

Master's degree (advantage)

Ferramentas

CTMS

EDC systems

Descrição da oferta de emprego

About the Role

Our client is a globally recognized pharmaceutical company seeking a dedicated and experienced Clinical Research Associate (CRA) to join their expanding remote operations. This is a fully remote position, offering the flexibility and autonomy to manage clinical trial activities from anywhere. You will play a critical role in ensuring the successful execution of clinical trials by monitoring study sites, ensuring data integrity, and maintaining compliance with regulatory standards and protocols. This role is vital for advancing our client's pipeline of innovative pharmaceutical products. The successful candidate will be a self-starter, highly organized, and possess exceptional communication skills to effectively liaise with investigators, site staff, and internal project teams. Embrace the opportunity to shape your career in clinical research with a company that values its remote workforce.

Key Responsibilities

• Conduct site initiation, interim monitoring, and site closure visits according to protocol and company SOPs.
• Verify the accuracy, completeness, and validity of clinical trial data through source data verification (SDV).
• Ensure compliance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and study protocols.
• Manage and maintain relationships with principal investigators and site staff, providing necessary support and training.
• Monitor subject recruitment and retention efforts at assigned clinical sites.
• Prepare and submit accurate and timely monitoring visit reports.
• Identify and report adverse events (AEs) and serious adverse events (SAEs) according to reporting procedures.
• Troubleshoot and resolve site-level issues, escalating complex problems as needed.
• Participate in protocol and site-related training sessions and team meetings.
• Contribute to the development and review of study-related documents, such as protocols, case report forms (CRFs), and monitoring plans.

Requirements

• Bachelor's degree in a life science, nursing, or related field.
• A Master's degree is a plus.
• Minimum of 3 years of experience as a Clinical Research Associate in the pharmaceutical industry or a Contract Research Organization (CRO).
• Thorough understanding of ICH-GCP guidelines, FDA regulations, and other relevant regulatory requirements.
• Proven experience in monitoring clinical trials across various therapeutic areas.
• Excellent organizational, time management, and problem-solving skills.
• Strong interpersonal and communication skills, with the ability to build rapport with site personnel.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to work independently and manage a remote workload effectively.
• Must have access to a reliable internet connection and a suitable home office environment for remote work.
• Willingness to travel occasionally for essential in-person meetings or site visits as required.

Benefits

• Our client offers a highly competitive salary, excellent health, dental, and vision insurance, a generous retirement savings plan, paid time off, and opportunities for continuous professional development.
• As a fully remote employee, you benefit from the flexibility and work-life balance that comes with working from home.
• We provide the tools and support needed for you to excel in your role and advance your career within our organization.
• Join a forward-thinking company that embraces remote work and values your expertise.