Senior Clinical Research Associate (CRA)

Placements24; Gqeberha; Hybrid; ZAR 900.000 - 1.300.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Travel allowance

Hybrid work arrangement

Professional development

Zusammenfassung

Placements24 is seeking a Senior Clinical Research Associate for our client, a global CRO, to join in Port Elizabeth, Eastern Cape. This hybrid role combines on-site monitoring at trial sites with remote data review and collaboration with study teams to ensure data integrity and patient safety.

You will manage investigator relationships, oversee site readiness and enrollment, and prepare site visit reports.

Qualifikationen

• Bachelor's degree in life science or nursing or related field.
• Minimum of 5 years of experience as a Clinical Research Associate.
• Proven site monitoring experience for Phase II/III trials.
• Strong knowledge of GCP/ICH and regulatory requirements.

Aufgaben

• Perform on-site and remote monitoring visits for clinical trial sites.
• Ensure adherence to study protocols and SOPs and regulatory requirements.
• Verify data accuracy and completeness.
• Manage relationships with investigators and site staff and provide training.
• Prepare site visit reports and action item follow-up.
• Oversee site readiness and enrollment progress.
• Serve as primary contact for investigative sites.
• Contribute to study-related documents such as protocols and CRFs.

Kenntnisse

Site monitoring

Communication

Travel readiness

Organizational skills

Ausbildung

Bachelor's degree in life science

Tools

CTMS

EDC

Jobbeschreibung

About the Role

Our client, a global Contract Research Organization (CRO), is seeking a dedicated and experienced Senior Clinical Research Associate (CRA) to join their expanding team in Port Elizabeth, Eastern Cape, ZA. This hybrid role involves essential on-site monitoring of clinical trial sites to ensure data integrity, patient safety, and compliance with study protocols and Good Clinical Practice (GCP) guidelines. You will also have opportunities for remote work, focusing on data review, reporting, and collaboration with study teams. This position is critical for the successful execution of clinical trials, contributing to the development of new medicines. You will play a key role in managing relationships with investigators and site staff, ensuring the smooth progression of research studies in the region.

Key Responsibilities

• Perform on-site and remote monitoring visits (initiation, routine, and close-out) for clinical trial sites.
• Ensure compliance with study protocols, Standard Operating Procedures (SOPs), and applicable regulatory requirements (GCP, ICH).
• Verify the accuracy, completeness, and consistency of clinical data.
• Manage site relationships, provide training to site staff, and resolve site-level issues.
• Prepare site visit reports and follow up on action items.
• Oversee site readiness and enrollment progress.
• Act as a primary point of contact for investigative sites.
• Contribute to the development of study-related documents, such as protocols and Case Report Forms (CRFs).

Requirements

• Bachelor's degree in a life science, nursing, or related field.
• Minimum of 5 years of experience as a Clinical Research Associate.
• Proven experience in site monitoring for Phase II/III clinical trials.
• In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
• Excellent understanding of clinical trial processes and documentation.
• Strong communication, interpersonal, and organizational skills.
• Ability to travel to clinical sites as required (estimated 50-60% travel).
• Proficiency in clinical trial management systems (CTMS) and Electronic Data Capture (EDC) systems.
• Ability to work independently and manage time effectively in a hybrid work environment.

Benefits

• Our client offers a competitive salary, performance-based bonuses, and a comprehensive benefits package including medical, dental, and vision insurance, as well as a retirement savings plan.
• We provide a company car or travel allowance for site visits, and support for professional development through training and conference attendance.
• The hybrid work arrangement allows for a good work-life balance, combining essential field activities with remote administrative tasks.
• Our culture is collaborative and focused on achieving excellence in clinical research.