Senior Pharmaceutical Clinical Research Associate (CRA)

Placements24; Randburg; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Medical aid

Life insurance

Retirement savings

Career progression

Job summary

Placements24 in Randburg, Gauteng, is seeking an experienced Senior Pharmaceutical Clinical Research Associate (CRA) to oversee site conduct, ensure GCP/ICH compliance, and monitor trials across multiple sites.

The role requires a life science degree and at least 5 years as a CRA, with the ability to travel up to 60%. The position offers a hybrid work setup with potential career progression within a leading CRO.

Qualifications

• Bachelor's degree in life science or related field.
• Minimum 5 years as a CRA in pharma industry or CRO.
• Strong knowledge of GCP, ICH guidelines, and regulatory reqs.

Responsibilities

• Perform site selection, initiation, monitoring and close-out visits.
• Ensure accurate data collection and SDV through source data verification.
• Train and support investigators and site staff on procedures.
• Oversee multiple sites and ensure regulatory compliance.

Skills

Site monitoring

GCP knowledge

ICH guidelines

CTMS

EDC systems

Regulatory compliance

Travel up to 60%

Strong communication

Education

Bachelor's degree in life sciences

Tools

CTMS

EDC

Job description

About the Role

Our client, a leading global Contract Research Organization (CRO) specializing in clinical trials, is seeking an experienced Senior Pharmaceutical Clinical Research Associate (CRA) to join their esteemed team in Randburg, Gauteng. This critical role involves overseeing the conduct of clinical trials at investigator sites, ensuring compliance with study protocols, regulatory requirements, and Good Clinical Practices (GCP). The Senior CRA will be responsible for site selection, initiation, monitoring, and close-out activities, playing a vital part in bringing new pharmaceutical treatments to market. This position offers the opportunity to work on diverse and cutting-edge clinical research projects.

Key Responsibilities

• Perform site selection, initiation, interim monitoring, and close-out visits in accordance with clinical trial protocols and GCP guidelines.
• Ensure accurate, complete, and timely collection of clinical data through source data verification (SDV) and review of study documentation.
• Train and support investigators and site staff on study procedures, protocols, and regulatory requirements.
• Manage multiple clinical trial sites and ensure compliance with all ethical and regulatory standards.
• Identify, track, and resolve site-level issues, escalating critical issues as necessary.
• Oversee site budgets and contracts, ensuring adherence to financial agreements.
• Prepare site visit reports, follow-up letters, and other essential study documentation.
• Contribute to the development and review of study protocols, Case Report Forms (CRFs), and other clinical trial documents.
• Maintain effective communication with study teams, investigators, and other stakeholders.
• Ensure timely submission of essential documents to the regulatory authorities and ethics committees.

Requirements

• Bachelor's degree in a life science, nursing, pharmacy, or a related healthcare field.
• Minimum of 5 years of experience as a Clinical Research Associate (CRA) in the pharmaceutical industry or a CRO.
• In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements for clinical trials.
• Proven experience in monitoring clinical trials across various therapeutic areas.
• Strong understanding of clinical trial processes, from initiation to close-out.
• Excellent communication, interpersonal, and organizational skills.
• Ability to travel frequently (up to 60%) to investigator sites within the assigned region.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Detail-oriented with strong problem-solving and critical thinking abilities.
• Demonstrated ability to work independently and manage workload effectively.

Benefits

Our client offers a competitive salary package, performance-based bonuses, and excellent benefits including medical aid, life insurance, and retirement savings plans. This hybrid role provides the flexibility to work remotely when not on-site at investigator locations around Randburg, Gauteng and surrounding areas. Opportunities for professional development, continued education, and career progression within a leading CRO are extensive. Join a dedicated team focused on advancing medical research and improving patient outcomes.