Clinical Research Associate (Remote)

Placements24; Kempton Park; Remote; ZAR 600,000 - 1,000,000; Full time

Benefits offered by this job

Competitive salary

Medical coverage

Dental coverage

Vision coverage

Retirement plan

Leave entitlement

Training & development

Home office allowance

Flexible schedule

Job summary

Placements24 is seeking a dedicated Clinical Research Associate for a fully remote position. You will monitor clinical trial sites, verify data integrity, and ensure regulatory compliance across multiple studies.

This role supports a remote-first culture and requires strong scientific rigor and independence. The successful candidate will hold a life science or nursing degree, have at least 3 years of CRA experience, and be adept with EDC and CTMS tools while traveling occasionally for essential

Qualifications

• Bachelor's degree in life science, nursing, or related discipline.
• Minimum of 3 years of direct CRA experience.
• In-depth knowledge of clinical trial processes, GCP, ICH guidelines, and regulatory requirements.
• Proven ability to manage multiple trials and sites.
• Excellent organizational, analytical, and problem-solving skills.
• Proficiency in using EDC systems and CTMS.

Responsibilities

• Conduct site visits (initiation, monitoring, close-out) according to protocol and regulatory requirements, primarily remotely through virtual tools.
• Verify accuracy, completeness, and compliance of clinical trial data by reviewing source documents and EDC systems.
• Ensure adherence to GCP, SOPs, and study protocols.
• Serve as the primary contact for assigned sites, addressing questions and resolving issues.
• Manage study site recruitment and enrollment activities with investigators and site staff.
• Prepare and submit essential study documents to regulators and IRBs/Ethics Committees.
• Monitor subject safety and report adverse events (AEs) and SAEs as required.
• Oversee study drug accountability at clinical sites.
• Communicate effectively with internal project teams.

Skills

Remote work

Multisite management

Communication

Education

Bachelor's degree in life science / nursing / related discipline

Tools

EDC systems

CTMS

Job description

About the Role

Our client is a renowned pharmaceutical company seeking a dedicated Clinical Research Associate (CRA) to join their expanding team. This position is a fully remote opportunity, allowing you to contribute significantly to our clinical trial operations without the need for physical office presence. You will play a crucial role in ensuring the smooth execution of clinical studies by monitoring trial sites, verifying data integrity, and upholding regulatory compliance. This role is essential for bringing life-saving therapies to patients and offers a chance to be part of a dedicated, distributed team committed to excellence. We champion a remote-first culture, empowering our employees with flexibility while maintaining the highest standards of professional conduct and scientific integrity. Your expertise will be vital in managing multiple studies and ensuring they meet all ethical and regulatory requirements, making a tangible difference in the advancement of healthcare. Join us in our mission to improve patient lives through rigorous clinical research conducted by a talented, globally dispersed team.

Key Responsibilities

• Conduct site visits (initiation, monitoring, close-out) according to protocol and regulatory requirements, primarily remotely through virtual tools.
• Verify the accuracy, completeness, and compliance of clinical trial data by reviewing source documents and electronic data capture (EDC) systems.
• Ensure adherence to Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), and study protocols.
• Serve as the primary point of contact for assigned clinical trial sites, addressing questions and resolving issues promptly.
• Manage study site recruitment and enrollment activities, working closely with investigators and site staff.
• Prepare and submit essential study documents to the appropriate regulatory authorities and Institutional Review Boards (IRBs)/Ethics Committees.
• Monitor subject safety and report adverse events (AEs) and serious adverse events (SAEs) according to protocol and regulatory standards.
• Oversee study drug accountability and management at clinical sites.
• Communicate effectively with internal project teams, including study managers, data managers, and investigators.

Requirements

• Bachelor's degree in a life science, nursing, or related discipline.
• Minimum of 3 years of direct experience as a Clinical Research Associate.
• In-depth knowledge of clinical trial processes, GCP, ICH guidelines, and regulatory requirements.
• Proven ability to manage multiple clinical trials and sites simultaneously.
• Excellent organizational, analytical, and problem-solving skills.
• Proficiency in using EDC systems, CTMS (Clinical Trial Management Systems), and other clinical research software.
• Strong interpersonal and communication skills, essential for remote team collaboration and site interactions.
• Ability to work independently and proactively in a remote setting.
• Willingness to travel occasionally for essential site visits or team meetings, as needed.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive medical, dental, and vision coverage.
• Retirement savings plan.
• Generous annual leave and public holiday entitlement.
• Continuous training and professional development opportunities.
• Home office equipment allowance.
• Flexible work schedule options.