Senior Clinical Research Associate (Pharmaceuticals)

Placements24

Randburg

Hybrid

ZAR 900,000 - 1,200,000

Full time

36 hours ago
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Benefits offered by this job

Competitive salary package
Bonuses and incentives
Medical, dental, and vision coverage
PTO and holidays
Retirement plan
Travel reimbursement
Professional development

Job summary

Placements24 in Randburg is seeking a Senior Clinical Research Associate to oversee site monitoring, ensure data integrity, and enforce GCP and regulatory standards across multiple sites. This role requires a Bachelor’s degree in life sciences and 5–7 years of CRA experience.

You will mentor junior CRAs, manage site relationships, and coordinate with sponsors to drive trial progress. Travel up to 60% is required.

Qualifications

  • Bachelor’s degree in Life Sciences, Nursing, Pharmacy or related field.
  • 5–7 years of CRA experience in pharma.
  • Strong knowledge of GCP/ICH guidelines and regulatory requirements.
  • Experience monitoring sites and ensuring data integrity.
  • Proven ability to travel up to 60% and manage multiple sites.

Responsibilities

  • Conduct site initiation, monitoring, and close-out visits per GCP and protocol.
  • Verify data accuracy and consistency from investigational sites.
  • Ensure adherence to study protocols and informed consent procedures.
  • Manage investigational product accountability and destruction.
  • Mentor junior CRAs and provide site staff training.
  • Prepare monitoring visit reports and follow up actions with sites.
  • Collaborate with sponsors on study documentation and protocols.

Skills

GCP/ICH knowledge
Data integrity
Site monitoring
Regulatory compliance
Communication

Education

Bachelor’s degree in Life Sciences, Nursing, Pharmacy

Tools

CTMS
EDC systems

Job description

About the Role

Our client, a prominent global pharmaceutical company focused on developing groundbreaking treatments, is seeking a highly experienced Senior Clinical Research Associate (CRA) to contribute to their vital research initiatives in Randburg . This role is pivotal in overseeing and managing clinical trial sites, ensuring the integrity of data, and maintaining compliance with protocols and regulatory standards. The Senior CRA will act as a key liaison between the sponsor and investigational sites, providing expert guidance and support. This is an exceptional career opportunity for a seasoned professional looking to advance their career in clinical research within a company renowned for its commitment to scientific innovation and patient care.

Key Responsibilities
  • Conduct site initiation, monitoring, and close-out visits for clinical trials in accordance with Good Clinical Practice (GCP) and protocol requirements.
  • Verify the accuracy, completeness, and consistency of clinical data collected at investigational sites.
  • Ensure adherence to study protocols, informed consent procedures, and all applicable regulatory requirements.
  • Manage investigational product accountability and drug destruction at study sites.
  • Act as the primary point of contact for clinical investigators and site staff, providing training and ongoing support.
  • Identify, document, and resolve site-level issues and deviations in a timely manner.
  • Prepare monitoring visit reports and follow up on action items with study sites.
  • Contribute to the development of clinical trial protocols, case report forms (CRFs), and other study-related documents.
  • Mentor and provide guidance to junior CRAs and study site personnel.
  • Participate in team meetings and contribute to the overall success of clinical research projects.
Requirements
  • Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
  • A minimum of 5-7 years of experience as a Clinical Research Associate in the pharmaceutical industry.
  • Thorough understanding of GCP, ICH guidelines, and relevant regulatory requirements.
  • Proven experience in monitoring clinical trial sites and managing data integrity.
  • Excellent interpersonal, communication, and organizational skills.
  • Strong ability to interpret clinical trial protocols and identify protocol deviations.
  • Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
  • Ability to travel to investigational sites as required (up to 60%).
  • Demonstrated ability to work independently and manage a diverse workload effectively.
Benefits
  • Competitive salary package commensurate with experience.
  • Performance-based bonuses and incentives.
  • Comprehensive medical, dental, and vision coverage.
  • Generous paid time off and company holidays.
  • Retirement savings plan.
  • Travel expenses fully reimbursed.
  • Opportunities for professional development and career advancement.
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