Senior Clinical Research Associate (Pharmaceutical)

Placements24; Mossel Bay; Hybrid; ZAR 750,000 - 1,100,000; Full time

Benefits offered by this job

Competitive salary

Car allowance

Health and retirement benefits

Hybrid work model

Job summary

Placements24 in Mossel Bay, Western Cape, seeks a Senior Clinical Research Associate to oversee pharmaceutical trials at multiple sites. You will monitor site activities, ensure data integrity and patient safety, and enforce GCP/ICH compliance across study protocols.

The role requires 5+ years as a CRA, strong CTMS/EDC proficiency, excellent communication, and the ability to travel as needed. Hybrid work arrangements apply.

Qualifications

• Bachelor's degree in life science, nursing or related field.
• Minimum of 5 years as a Clinical Research Associate in pharma trials.
• Strong knowledge of GCP, ICH guidelines and local regs.
• Experience managing multiple study sites and complex protocols.
• Proficient with CTMS and EDC systems.
• Willingness to travel to study sites for hybrid work.
• Located in or willing to commute to Mossel Bay, Western Cape.

Responsibilities

• Conduct pre-study, initiation, interim, and close-out visits at clinical trial sites.
• Monitor clinical trial conduct to ensure compliance with GCP, protocols, and regulatory guidelines.
• Verify the accuracy, completeness, and integrity of clinical data through source data verification.
• Manage study site activities, including patient recruitment, informed consent, and drug accountability.
• Build and maintain strong relationships with investigators, site staff, and study participants.
• Identify and report adverse events and serious adverse events promptly.
• Ensure timely submission of essential documents and regulatory compliance at study sites.
• Provide training and support to site personnel.
• Prepare detailed monitoring visit reports and follow up on action items.
• Contribute to the development of study protocols and other clinical trial documents.

Skills

Interpersonal skills

Communication

Organizational skills

Data analysis

Attention to detail

Education

Bachelor's degree in life science or related field

Tools

CTMS

EDC systems

Job description

About the Role

A leading contract research organization (CRO) is seeking an experienced Senior Clinical Research Associate (CRA) to join their expanding team, focusing on pharmaceutical clinical trials. This position, based in the picturesque region of Mossel Bay, Western Cape, involves managing and monitoring clinical trial sites to ensure data integrity, patient safety, and adherence to protocols and regulatory requirements. The ideal candidate will have a strong background in clinical trial management and a passion for advancing medical research. This is a vital role in ensuring the successful execution of clinical studies that contribute to the development of new and improved pharmaceutical treatments. Your expertise will directly impact the progress of life-changing therapies.

Key Responsibilities

• Conduct pre-study, initiation, interim, and close-out visits at clinical trial sites.
• Monitor clinical trial conduct to ensure compliance with Good Clinical Practice (GCP), protocols, and regulatory guidelines.
• Verify the accuracy, completeness, and integrity of clinical data through source data verification.
• Manage study site activities, including patient recruitment, informed consent, and drug accountability.
• Build and maintain strong relationships with investigators, site staff, and study participants.
• Identify and report adverse events and serious adverse events promptly.
• Ensure timely submission of essential documents and regulatory compliance at study sites.
• Provide training and support to site personnel.
• Prepare detailed monitoring visit reports and follow up on action items.
• Contribute to the development of study protocols and other clinical trial documents.

Requirements

• Bachelor's degree in a life science, nursing, or related healthcare field.
• Minimum of 5 years of experience as a Clinical Research Associate, with a focus on pharmaceutical trials.
• Comprehensive knowledge of GCP, ICH guidelines, and local regulatory requirements.
• Proven ability to manage multiple study sites and complex protocols.
• Excellent interpersonal, communication, and organizational skills.
• Strong attention to detail and ability to analyze data effectively.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to travel to study sites as required.
• Experience working with pharmaceutical sponsors is highly desirable.
• Must be located in or willing to commute to Mossel Bay, Western Cape for hybrid work arrangements.

Benefits

• Our client offers a competitive salary, a car allowance, comprehensive health and retirement benefits, and extensive training and professional development opportunities.
• This hybrid role provides a blend of on-site and remote work, offering flexibility.
• The opportunity to work on cutting-edge pharmaceutical research in a beautiful coastal location like Mossel Bay, Western Cape, is a significant advantage.
• We foster a collaborative and growth-oriented culture.