Senior Clinical Research Associate (Remote)

Placements24; Midrand; Hybrid; ZAR 900.000 - 1.500.000; Vollzeit

Benefits dieser Stelle

Competitive compensation

Health insurance coverage

Retirement plan

Paid time off

Professional development

Home office support

Fully remote role

Zusammenfassung

Placements24 is seeking a Senior Clinical Research Associate for a fully remote role in South Africa. You will oversee site visits, ensure GCP compliance, and verify data quality across trials from I to IV while communicating with investigators and staff.

Ideal candidates have a life science degree (advanced degree preferred), 5+ years of CRA experience, and strong CTMS/EDC skills. Travel for essential visits is expected, with a home office setup and remote collaboration essential.

Qualifikationen

• Bachelor's degree in a life science, nursing, or related field; advanced degree preferred.
• Minimum of 5 years as a Clinical Research Associate in pharma.
• Deep knowledge of ICH-GCP and regulatory requirements.
• Experience monitoring multiple phases (I–IV) of clinical trials.
• Strong written and verbal communication and remote work discipline.
• Proficiency with CTMS and EDC systems.

Aufgaben

• Conduct site initiation, monitoring, and close-out visits for protocol adherence and data accuracy.
• Ensure compliance with GCP, FDA regulations, and applicable rules.
• Review source documents against CRFs for accuracy and completeness.
• Maintain investigational site files and documentation.
• Be the primary contact for sites, guiding investigators and staff.
• Monitor patient recruitment and retention and address challenges.
• Prepare and present monitoring visit reports timely.
• Collaborate with data management, medical affairs, and regulatory teams.
• Identify and resolve data discrepancies and protocol deviations.

Kenntnisse

Communication

Organizational skills

Remote work

Attention to detail

Independent work

Ausbildung

Bachelor's degree in life science

Advanced degree preferred

Tools

CTMS

EDC

Jobbeschreibung

About the Role

Our client, a leading innovator in pharmaceutical research and development, is seeking a highly motivated and experienced Senior Clinical Research Associate (CRA) to join their dynamic team. This fully remote position offers a unique opportunity to contribute to groundbreaking clinical trials from the comfort of your home office. As a remote-first organization, we foster a collaborative and supportive environment, ensuring seamless communication and productivity across distributed teams. You will play a crucial role in ensuring the quality and integrity of clinical data, adhering to strict regulatory standards and company protocols. This position is ideal for an independent, detail-oriented professional who thrives in a flexible work setting and possesses a deep understanding of clinical trial management. The **Midrand** region, while not your physical workspace, remains a key operational hub for our client's South African endeavors.

Key Responsibilities

• Conduct site initiation visits, interim monitoring visits, and close-out visits to assess protocol compliance and data accuracy.
• Ensure adherence to Good Clinical Practice (GCP) guidelines, FDA regulations, and other applicable regulatory requirements.
• Review and verify source documents against case report forms (CRFs) for accuracy and completeness.
• Manage and maintain investigational site files, ensuring all documentation is up-to-date and readily accessible.
• Serve as the primary point of contact for assigned clinical sites, providing ongoing support and guidance to investigators and site staff.
• Monitor patient recruitment and retention, identifying and addressing any challenges proactively.
• Prepare and present monitoring visit reports in a timely and comprehensive manner.
• Collaborate with cross-functional teams, including data management, medical affairs, and regulatory affairs, to ensure successful trial execution.
• Identify, track, and resolve data discrepancies and protocol deviations.

Requirements

• Bachelor's degree in a life science, nursing, or related field; advanced degree preferred.
• Minimum of 5 years of progressive experience as a Clinical Research Associate in the pharmaceutical industry.
• In-depth knowledge of ICH-GCP guidelines and relevant regulatory requirements.
• Proven experience in monitoring various phases of clinical trials (Phase I-IV).
• Excellent written and verbal communication skills, with the ability to effectively communicate complex information.
• Strong organizational and time management skills, with a demonstrated ability to manage multiple priorities in a remote setting.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to work independently with minimal supervision and as part of a remote team.
• Must have a dedicated home office space with reliable internet connectivity.
• Willingness to travel for essential site visits as required, although the role is primarily remote.

Benefits

• Our client offers a competitive compensation package, including a generous annual salary and performance-based bonuses.
• Employees benefit from comprehensive health insurance coverage, including medical, dental, and vision plans.
• A robust retirement savings plan is available, along with ample paid time off, including vacation, sick leave, and public holidays.
• Professional development opportunities, including ongoing training and conference attendance, are actively encouraged.
• Support for home office setup and maintenance is provided.
• This is a truly remote role, offering unparalleled flexibility.