Clinical Research Associate (Pharmaceutical)

Placements24; Midrand; Híbrido; ZAR 600 000 - 900 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical aid

Retirement fund contributions

Performance bonus

Resumo da oferta

Placements24 invites applications for a Clinical Research Associate based in Midrand, Gauteng. The role covers site monitoring, data integrity, and regulatory compliance across multiple sites, with a mix of on-site and remote oversight under a hybrid arrangement.

You will ensure adherence to protocol, perform visits, and maintain high-quality documentation while collaborating with investigators and sponsors to advance clinical trials.

Qualificações

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field.
• 3–5 years clinical research experience as a CRA in pharma.
• Strong knowledge of GCP, ICH guidelines, and regulatory requirements.
• Experience with CTMS and EDC systems.
• Willingness to travel to sites within Midrand and surrounding regions.

Responsabilidades

• Monitor clinical trial sites to ensure adherence to protocol, SOPs, GCP, and regulatory requirements.
• Perform site initiation visits, routine monitoring visits, and close-out visits.
• Verify accuracy, completeness, and timeliness of data entered into CRFs and EDC systems.
• Ensure proper conduct of the study at the site level, including informed consent and adverse event reporting.
• Build and maintain relationships with investigators, site staff, and sponsors.
• Identify and report site issues and implement CAPAs.
• Prepare monitoring visit reports and follow up on actions.
• Train site personnel on study procedures and requirements.
• Maintain study documentation in a timely and accurate manner.
• Participate in investigator meetings and sponsor team meetings.

Conhecimentos

GCP & ICH guidelines

Site monitoring

CTMS usage

Data integrity

Formação académica

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

Ferramentas

CTMS

EDC systems

Descrição da oferta de emprego

About the Role

Our client, a dynamic pharmaceutical company with a strong pipeline, is looking for a diligent and experienced Clinical Research Associate (CRA) to join their team, primarily based in Midrand, Gauteng . This role is fundamental to ensuring the successful execution of clinical trials in compliance with Good Clinical Practice (GCP) and all applicable regulatory requirements. The CRA will be responsible for monitoring clinical trial sites, ensuring data accuracy and integrity, and managing site relationships. This position offers a great opportunity to work on diverse therapeutic areas and contribute to the advancement of new medicines. We seek a proactive individual with excellent organizational skills and a keen eye for detail, who can effectively manage multiple sites and ensure patient safety throughout the trial process. The role involves a mix of site visits and remote monitoring, offering a hybrid work arrangement for professionals in the Midrand, Gauteng area.

Key Responsibilities

• Monitor clinical trial sites to ensure adherence to protocol, SOPs, GCP, and regulatory requirements.
• Perform site initiation visits, routine monitoring visits, and close-out visits.
• Verify the accuracy, completeness, and timeliness of clinical data entered into the Case Report Forms (CRFs) and electronic data capture (EDC) systems.
• Ensure proper conduct of the study at the site level, including informed consent process, investigational product accountability, and adverse event reporting.
• Build and maintain strong working relationships with investigators, site staff, and study sponsors.
• Identify and report site issues and risks, and implement corrective and preventive actions (CAPAs).
• Prepare monitoring visit reports and follow up on action items.
• Train site personnel on study-specific procedures and requirements.
• Ensure all study-related documentation is maintained in a timely and accurate manner.
• Participate in investigator meetings and sponsor team meetings as required.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
• Minimum of 3-5 years of experience as a Clinical Research Associate in the pharmaceutical industry.
• Thorough understanding of GCP, ICH guidelines, and relevant local and international regulations.
• Experience with various clinical trial phases (Phase I-IV).
• Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Excellent monitoring skills with a strong attention to detail and accuracy.
• Strong organizational and time management abilities.
• Effective communication, interpersonal, and problem-solving skills.
• Ability to travel to clinical trial sites within Midrand, Gauteng and surrounding regions as needed.
• Self-motivated and able to work independently as well as part of a team.

Benefits

• Our client offers a competitive salary, a comprehensive benefits package including medical aid, retirement fund contributions, and performance bonuses.
• This hybrid role provides flexibility, allowing you to balance work and life while contributing to important clinical research initiatives from Midrand, Gauteng .
• We support continuous professional development and offer career advancement opportunities within a growing pharmaceutical organization committed to innovation and patient well-being.