Clinical Research Associate (CRA) - Pharmaceutical

Placements24; Soweto; On-site; ZAR 450,000 - 600,000; Full time

Benefits offered by this job

Medical aid

Pension fund

Travel allowances

Job summary

Placements24 is seeking a dedicated Clinical Research Associate to monitor trials in Soweto, Gauteng. You will ensure data integrity, patient safety, and regulatory compliance while coordinating site activities and supporting staff. The role involves travel to investigational sites and collaboration with the sponsor to maintain high-quality trial conduct. Ideal candidates have 3+ years of CRA experience and solid knowledge of GCP/ICH.

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field.
• Minimum 3 years of CRA or similar trial monitoring experience.
• Strong knowledge of GCP and ICH guidelines and regulatory requirements.
• Ability to travel to investigational sites as required.
• South Africa work eligibility is required.

Responsibilities

• Perform site selection, initiation, interim monitoring, and close-out visits per the Monitoring Plan.
• Ensure compliance with GCP, protocols, and regulations.
• Verify data accuracy in CRFs and electronic databases.
• Monitor patient safety and report adverse events per protocol.
• Train and support site staff on study procedures.
• Coordinate sponsor communication with investigational sites.
• Resolve data discrepancies and ensure timely queries.
• Prepare monitoring visit reports and maintain site files.
• Identify risks at investigational sites and escalate appropriately.
• Ensure all regulatory and ethical guidelines for clinical research are followed.

Skills

GCP

ICH guidelines

CTMS

EDC

Travel ready

Communication

Organization

Regulatory knowledge

Education

Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field

Tools

CTMS

EDC

Job description

About the Role

Our client, a globally recognized pharmaceutical company, is seeking a dedicated and diligent Clinical Research Associate (CRA) to join their clinical operations team in Soweto, Gauteng . This crucial role involves monitoring clinical trials at investigational sites to ensure data integrity, patient safety, and adherence to protocols and regulatory requirements (GCP, ICH). You will be responsible for site initiation, routine monitoring, and site closure activities. The ideal candidate will have a strong understanding of clinical trial processes, excellent communication and organizational skills, and a commitment to ethical research practices. This is an excellent opportunity to contribute to the advancement of innovative therapies and build a rewarding career in clinical research.

Key Responsibilities

• Perform site selection, initiation, interim monitoring, and close-out visits in accordance with the Clinical Monitoring Plan.
• Ensure compliance with Good Clinical Practice (GCP) guidelines, study protocols, and applicable regulations.
• Verify the accuracy, completeness, and consistency of data entered into the Case Report Forms (CRFs) and electronic databases.
• Monitor patient safety and ensure all adverse events and serious adverse events are reported according to protocol.
• Train and support study site staff on study-related procedures and requirements.
• Manage communication between the sponsor and investigational sites.
• Resolve data discrepancies and ensure timely query resolution.
• Prepare monitoring visit reports and maintain accurate site files.
• Identify and elevate potential issues or risks at investigational sites.
• Ensure compliance with all regulatory and ethical guidelines for clinical research.

Requirements

• A Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
• A minimum of 3 years of experience as a Clinical Research Associate (CRA) or in a similar clinical trial monitoring role.
• In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
• Experience with various therapeutic areas is a plus.
• Strong understanding of clinical trial processes and documentation.
• Excellent monitoring, organizational, and time management skills.
• Exceptional interpersonal and communication skills, with the ability to build rapport with site staff.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to travel to investigational sites as required.
• Must be legally authorized to work in South Africa.

Benefits

• This position offers a competitive salary, comprehensive medical aid, a pension fund, and travel allowances.

Employees in Soweto benefit from a supportive team environment and the opportunity to work on groundbreaking clinical trials that impact patient health.