Senior Clinical Research Associate - Pharmaceutical Development

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

Benefits offered by this job

Competitive salary package

Comprehensive health insurance

Performance-based bonuses

Professional development opportunities

Paid time off and holidays

Retirement savings plan

Access to state-of-the-art facilities

Job summary

Placements24 in Midrand, South Africa is seeking a Senior Clinical Research Associate (SCRA) to oversee and manage clinical trial activities, ensuring GCP compliance and adherence to SOPs. The SCRA will focus on site management, monitoring, and data verification to support development of new therapies.

The ideal candidate holds a life sciences-related Bachelor's degree, 5+ years CRA experience, proficiency with CTMS and EDC systems, and willingness to travel up to 40% within South Africa,

Qualifications

• Must have strong knowledge of GCP and ICH guidelines.
• Experience in site management, monitoring, and data verification.
• Proven ability to train and mentor junior staff.

Responsibilities

• Oversee all aspects of assigned clinical trials from site initiation to close-out.
• Ensure compliance with GCP, regulatory requirements, and SOPs.
• Conduct site visits and assess protocol adherence and subject safety.
• Prepare progress reports for management and sponsors.
• Manage study budgets and timelines, escalating issues as needed.

Skills

Communication skills

Interpersonal skills

Time management

Travel readiness

Problem-solving

Education

Bachelor's degree in life sciences, nursing, pharmacy, or related field

Master's degree (preferred)

Tools

CTMS

EDC systems

Job description

About the Role

Our client, a leading pharmaceutical innovator, is seeking a highly motivated and experienced Senior Clinical Research Associate (SCRA) to join their dynamic team. This pivotal role involves overseeing and managing clinical trial activities, ensuring adherence to regulatory standards and company protocols. The SCRA will play a crucial part in the successful execution of groundbreaking research, contributing directly to the development of life-changing medications. This position offers a unique opportunity to work within a collaborative environment and contribute to cutting-edge pharmaceutical advancements in **Midrand, Gauteng**. We are committed to fostering a culture of continuous learning and professional growth for our employees, ensuring they have the resources and support needed to excel. The ideal candidate will be a proactive problem-solver with a keen eye for detail and a passion for scientific progress. This role is essential to our client's mission of bringing innovative therapies to market and improving patient outcomes globally.

Key Responsibilities

• Oversee and manage all aspects of assigned clinical trials, from site selection and initiation to monitoring, close-out, and data analysis.
• Ensure compliance with Good Clinical Practice (GCP), applicable regulations (e.g., FDA, EMA), and company Standard Operating Procedures (SOPs).
• Conduct site visits, including pre-study, initiation, interim monitoring, and close-out visits, to assess protocol adherence, data accuracy, and subject safety.
• Train and mentor junior CRAs and site staff on protocol requirements, regulatory guidelines, and study procedures.
• Develop and maintain effective working relationships with investigators, site staff, and study sponsors.
• Prepare and present study progress reports to project teams and management.
• Manage study budgets and timelines effectively, ensuring milestones are met.
• Identify and resolve study-related issues, escalating when necessary.

Requirements

• Bachelor's degree in life sciences, nursing, pharmacy, or a related field. A Master's degree is a plus.
• Minimum of 5 years of experience as a Clinical Research Associate in the pharmaceutical industry.
• Extensive knowledge of clinical trial processes, GCP, ICH guidelines, and regulatory requirements.
• Proven experience in site management, monitoring, and data verification.
• Excellent communication, interpersonal, and negotiation skills.
• Strong organizational and time management abilities, with the capacity to manage multiple priorities.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to travel to clinical sites as required, approximately 40% of the time within the **Midrand, Gauteng** region and potentially broader South Africa.
• Fluency in English is essential.

Benefits

• Competitive salary package commensurate with experience.
• Comprehensive health insurance coverage.
• Performance-based bonuses.
• Opportunities for professional development and career advancement within a growing pharmaceutical company.
• Paid time off and holidays.
• Retirement savings plan.
• Access to state-of-the-art facilities and technologies.
• A collaborative and supportive work environment focused on innovation and patient well-being.