Innovative Research Chemical Engineer - R&D Scientist

Placements24; Klerksdorp; Vor Ort; ZAR 900.000 - 1.100.000; Vollzeit

Zusammenfassung

Placements24 is recruiting a Senior Clinical Research Associate for a leading pharmaceutical client. The role is based in Klerksdorp, North West, and focuses on start-up, conduct, and close-out of studies, ensuring adherence to GCP, ICH guidelines, and regulatory standards.

The SCRA will train site staff, manage relationships with investigators, and collaborate with data management, biostatistics, and medical affairs to drive study success and data integrity.

Qualifikationen

• Bachelor's degree in a life science, nursing, or related field required.
• Master's degree or equivalent experience is a plus.

Aufgaben

• Oversee and manage all aspects of clinical trial conduct at assigned sites in line with GCP and protocol.
• Serve as liaison between sponsor and investigative sites.
• Monitor study progress, recruitment, and data collection; resolve queries.
• Conduct site initiation, interim monitoring, and close-out visits with documented findings.
• Ensure timely submission of regulatory documents and essential study materials.
• Maintain study documents and ensure up-to-date records.

Kenntnisse

GCP knowledge

ICH guidelines

Regulatory compliance

Clinical trial monitoring

Site management

Training staff

Data integrity

Ausbildung

Bachelor's degree in life science, nursing, or related field

Master's degree or equivalent experience

Jobbeschreibung

Senior Clinical Research Associate - Pharmaceutical Development

About the Role Our client, a leading pharmaceutical company, is seeking a highly experienced and motivated Senior Clinical Research Associate (SCRA) to join their dynamic team in Klerksdorp, North West . This critical role involves overseeing and managing clinical trial activities to ensure compliance with protocols, regulatory requirements, and ethical standards. The SCRA will play a pivotal part in the successful execution of studies, contributing to the advancement of groundbreaking pharmaceutical treatments. You will be instrumental in driving study start-up, conduct, and close-out phases, working closely with investigators, site staff, and internal stakeholders. This is an exceptional opportunity to make a significant impact in a challenging and rewarding environment within the pharmaceutical industry . The role requires a strong understanding of drug development processes and a commitment to data integrity and patient safety.

Key Responsibilities

• Oversee and manage all aspects of clinical trial conduct at assigned sites, ensuring adherence to Good Clinical Practice (GCP) guidelines, protocol requirements, and regulatory standards.
• Serve as the primary liaison between the sponsor and the investigative sites, fostering strong working relationships.
• Monitor study progress, track patient recruitment, and ensure timely data collection and query resolution.
• Conduct site initiation, interim monitoring, and close-out visits, documenting findings and action items.
• Ensure accurate and timely submission of regulatory documents and study-related materials.
• Manage and maintain essential study documents, ensuring they are up-to-date and readily available.
• Identify and report adverse events and serious adverse events according to protocol and regulatory guidelines.
• Provide training and support to site staff on study procedures, protocol amendments, and regulatory compliance.
• Contribute to the development and review of study-related documents, including protocols, informed consent forms, and case report forms.
• Collaborate with cross-functional teams, including data management, biostatistics, and medical affairs.

Requirements

• Bachelor's degree in a life science, nursing, or related scientific field. A Master's degree or equivalent experience is a plus.
• Minimum of 5 years of experience as a Clinical Research Associate (CRA) in the pharmaceutical industry, with a proven track record of managing complex trials.
• In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements (e.g.,