Senior Clinical Research Associate (CRA)

Placements24; Vereeniging; Hybrid; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Hybrid work model

Travel reimbursement

Retirement savings plan

Life insurance

Job summary

Placements24 is seeking an experienced Senior Clinical Research Associate (CRA) to oversee clinical trials in and around Vereeniging. You will monitor study sites to ensure data integrity, timeliness, and strict adherence to protocols, GCP, and regulatory requirements.

This hybrid role involves on-site site visits with travel reimbursement, and remote work for reporting and administration. The successful candidate will mentor site staff, collaborate with investigators, and drive quality across

Qualifications

• Bachelor's degree in Life Sciences or Nursing; advanced degree preferred.
• Minimum 5 years as a Clinical Research Associate with site monitoring experience.
• Knowledge of ICH-GCP, regulatory requirements and trial processes.
• Strong communication and organizational abilities.

Responsibilities

• Conduct pre-study, initiation, routine monitoring, and close-out visits at sites.
• Ensure compliance with study protocols, ICH-GCP, FDA regulations, and SOPs.
• Verify accuracy and completeness of source data and trial documentation.
• Train and mentor site staff on procedures and regulatory requirements.
• Communicate effectively with investigators, site personnel and project teams.
• Identify deviations and protocol violations and report them.

Skills

Strong communication

Organizational skills

Site monitoring

GCP/ICH knowledge

Regulatory compliance

Education

Bachelor's degree in Life Sciences / Nursing

Advanced degree preferred

Job description

About the Role

Our client is seeking an experienced and highly organized Senior Clinical Research Associate (CRA) to oversee clinical trials in and around the Vereeniging area. This role is crucial for ensuring the integrity, accuracy, and timeliness of clinical trial data by monitoring study sites. You will work collaboratively with investigators, site staff, and internal project teams to guarantee compliance with protocols, GCP, and regulatory requirements. This hybrid position involves significant on-site travel to clinical sites, balanced with remote work for reporting and administrative tasks.

Key Responsibilities

• Conduct pre-study, initiation, routine monitoring, and close-out visits at clinical trial sites.
• Ensure compliance with study protocols, FDA regulations, ICH-GCP guidelines, and company SOPs.
• Verify the accuracy, completeness, and consistency of source data and clinical trial documentation.
• Train and mentor site staff on study-related procedures and regulatory requirements.
• Communicate effectively with investigators, site personnel, and internal project management teams.
• Identify, document, and elevate any deviations, deficiencies, or protocol violations.

Requirements

• Bachelor's degree in Life Sciences, Nursing, or a related field; advanced degree preferred.
• Minimum of 5 years of experience as a Clinical Research Associate, with demonstrated success in site monitoring.
• In-depth knowledge of ICH-GCP, regulatory requirements, and clinical trial processes.
• Strong therapeutic area experience relevant to current company pipelines.
• Excellent communication, interpersonal, and organizational skills.

Benefits

• Highly competitive annual salary and performance bonuses.
• Hybrid work model with travel reimbursement for site visits.
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan and life insurance coverage.
• Significant opportunities for career growth and professional development in clinical operations.