Senior Clinical Research Associate (CRA) - Pharma

Placements24; Pretoria; Hybrid; ZAR 700.000 - 900.000; Vollzeit

Benefits dieser Stelle

Health insurance

Retirement plan

Paid time off

Professional development support

Travel allowance

Zusammenfassung

Placements24 is seeking a Senior Clinical Research Associate to join our remote team. You will monitor sites, ensure data integrity, and safeguard patient safety across trials in a global biopharmaceutical setting.

Responsibilities include site visits, data verification, protocol adherence, and collaboration with investigators. The role requires 5+ years CRA experience, strong GCP/ICH knowledge, and the ability to work independently from a home office.

Qualifikationen

• Bachelor's degree in life sciences or related healthcare field.
• Minimum of 5 years of experience as a Clinical Research Associate (CRA).
• Strong knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
• Proven experience in monitoring clinical trials across various therapeutic areas.
• Excellent understanding of clinical trial processes, from site initiation to close-out.
• Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Exceptional organizational, time management, and problem-solving skills.
• Strong verbal and written communication skills, with the ability to build rapport with site staff.
• Ability to work independently and manage a remote workload effectively.
• Willingness to travel to clinical sites as needed (typically 50-60% travel).

Aufgaben

• Conduct site initiation, interim monitoring, and close-out visits to ensure study compliance.
• Verify the accuracy and completeness of clinical trial data and source documentation.
• Ensure adherence to study protocols, SOPs, and GCP guidelines.
• Manage relationships with clinical investigators and site staff, providing training and support.
• Monitor patient safety and report adverse events according to regulatory requirements.
• Oversee drug accountability and investigational product management at sites.
• Resolve data discrepancies and query issues in a timely manner.
• Prepare monitoring visit reports and other relevant study documentation.
• Participate in study team meetings and provide updates on site performance.
• Contribute to the development and review of clinical trial protocols and CRFs.

Kenntnisse

GCP knowledge

Clinical trial monitoring

EDC/CTMS proficiency

Remote work

Travel readiness

Communication skills

Ausbildung

Bachelor's degree in life sciences or related healthcare field

Tools

EDC systems

CTMS

Jobbeschreibung

About the Role

Our client, a leading global biopharmaceutical company, is seeking a highly experienced and dedicated Senior Clinical Research Associate (CRA) to join their remote team. This role is instrumental in the successful execution of clinical trials, ensuring compliance with protocols, Good Clinical Practice (GCP), and regulatory requirements. As a remote CRA, you will be responsible for monitoring clinical trial sites, managing data integrity, and ensuring patient safety throughout the trial lifecycle. We are looking for a proactive individual with a strong understanding of clinical research methodologies and a passion for advancing medical treatments. This position offers significant flexibility and the opportunity to contribute to groundbreaking research from your home office. The ideal candidate possesses excellent organizational, communication, and interpersonal skills, coupled with a meticulous attention to detail. You will be a critical link between our research sites and our internal teams, driving the successful completion of vital clinical studies within the Pharmaceutical industry. Our commitment to a remote-first culture ensures you have the support needed to excel.

Key Responsibilities

• Conduct site initiation, interim monitoring, and close-out visits to ensure study compliance.
• Verify the accuracy and completeness of clinical trial data and source documentation.
• Ensure adherence to study protocols, Standard Operating Procedures (SOPs), and GCP guidelines.
• Manage relationships with clinical investigators and site staff, providing training and support.
• Monitor patient safety and report adverse events according to regulatory requirements.
• Oversee drug accountability and investigational product management at sites.
• Resolve data discrepancies and query issues in a timely manner.
• Prepare monitoring visit reports and other relevant study documentation.
• Participate in study team meetings and provide updates on site performance.
• Contribute to the development and review of clinical trial protocols and Case Report Forms (CRFs).

Requirements

• Bachelor's degree in a life science, nursing, or a related healthcare field.
• Minimum of 5 years of experience as a Clinical Research Associate (CRA).
• Strong knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
• Proven experience in monitoring clinical trials across various therapeutic areas.
• Excellent understanding of clinical trial processes, from site initiation to close-out.
• Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Exceptional organizational, time management, and problem-solving skills.
• Strong verbal and written communication skills, with the ability to build rapport with site staff.
• Ability to work independently and manage a remote workload effectively.
• Willingness to travel to clinical sites as needed (typically 50-60% travel).

Benefits

• Competitive annual salary of ZAR.
• Fully remote work arrangement.
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan with matching contributions.
• Generous paid time off and holidays.
• Professional development opportunities and support for certifications.
• Travel allowance and expense reimbursement.
• Access to advanced clinical trial technology.
• Opportunity to work on impactful clinical studies in the Pharmaceutical field.
• Supportive team environment and career growth prospects.