Clinical Research Associate - Cardiovascular Studies

Placements24; Birmingham; Hybrid; GBP 32,000 - 45,000; Full time

Benefits offered by this job

Competitive remuneration package

Professional development

Hybrid work model

Collaborative team

Job summary

Placements24 seeks a diligent Clinical Research Associate (CRA) to join a cardiovascular trials team in Gauteng. The role centers on monitoring trials to ensure data integrity, patient safety, and regulatory compliance, with a hybrid work model balancing remote monitoring and essential site visits.

The successful candidate will conduct site visits, perform SDV, train site staff, manage trial documents, and collaborate with data management and regulatory teams to support study delivery.

Qualifications

• Bachelor's degree in a life science, nursing, or related field.
• Master's degree or equivalent experience is a plus.
• Minimum of 3 years of experience as a Clinical Research Associate.
• Solid knowledge of ICH-GCP guidelines and regulatory requirements.
• Experience monitoring cardiovascular trials is preferred.
• Proven ability to perform site visits, SDV, and ensure regulatory compliance.

Responsibilities

• Conduct site visits (initiation, routine monitoring and close-out) to assess study conduct and compliance.
• Verify data accuracy through source data verification (SDV).
• Ensure adherence to protocol, plan, and regulatory requirements (GCP, FDA, ICH).
• Train and support site staff on study procedures and regulatory needs.
• Identify and resolve site-level issues and deviations promptly.
• Manage study supplies and investigational product at sites.
• Prepare monitoring visit reports with findings and action plans.
• Collaborate with data management, regulatory affairs, and project teams.
• Serve as the primary contact for assigned sites.
• Contribute to study-related documents like protocols and CRFs.

Skills

Site monitoring

Communication

Organizational skills

CTMS/EDC proficiency

Travel willingness

Regulatory knowledge

Education

Bachelor's degree in life science or nursing

Master's degree or equivalent experience

Tools

CTMS

EDC systems

Job description

About the Role

Our client is seeking a diligent and experienced Clinical Research Associate (CRA) to join their dynamic pharmaceutical team in Tembisa, Gauteng . This role involves the crucial task of monitoring clinical trials to ensure data accuracy, patient safety, and adherence to protocol and regulatory standards. As a CRA, you will be instrumental in the successful execution of studies, working closely with investigators, site staff, and internal project teams. This position offers a hybrid work model, allowing for a balance between remote work and essential site visits. The successful candidate will be responsible for site selection, initiation, monitoring, and closure activities, ensuring compliance with Good Clinical Practice (GCP) guidelines and all applicable regulations. You will play a vital role in bringing new cardiovascular therapies to market, contributing to advancements in patient care within this critical therapeutic area. The ideal candidate possesses strong organizational skills, a keen eye for detail, and a thorough understanding of clinical trial processes.

Key Responsibilities

• Conduct site visits (initiation, routine monitoring, and close-out) to assess study conduct and ensure compliance.
• Verify the accuracy, completeness, and integrity of clinical data through source data verification (SDV).
• Ensure adherence to the study protocol, investigational plan, and all applicable regulatory requirements (e.g., GCP, FDA, ICH).
• Train and support site staff on study procedures, regulatory requirements, and data collection.
• Identify, track, and resolve site-level issues and deviations in a timely manner.
• Manage study supplies and investigational product distribution and accountability at assigned sites.
• Prepare and present monitoring visit reports detailing findings and action plans.
• Collaborate with internal teams, including data management, regulatory affairs, and project management.
• Act as the primary point of contact for assigned clinical trial sites.
• Contribute to the development of study-related documents, such as protocols and case report forms (CRFs).

Requirements

• Bachelor's degree in a life science, nursing, or related field.
• A Master's degree or equivalent experience is a plus.
• Minimum of 3 years of experience as a Clinical Research Associate in the pharmaceutical or biotechnology industry.
• Demonstrated knowledge of ICH-GCP guidelines and other relevant regulatory requirements.
• Experience in monitoring clinical trials, preferably within the cardiovascular therapeutic area.
• Proven ability to conduct site visits, perform SDV, and ensure regulatory compliance.
• Excellent communication, interpersonal, and presentation skills.
• Strong organizational and time management skills, with the ability to prioritize and manage multiple tasks effectively.
• Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to travel to clinical sites as required for monitoring activities (estimated travel percentage will be provided).
• Detail-oriented with a strong commitment to data quality and patient safety.

Benefits

• Our client offers a competitive remuneration package, including a comprehensive medical aid plan, retirement fund contributions, and performance-based bonuses.
• Employees benefit from opportunities for professional development, including advanced training in clinical research methodologies and therapeutic areas.
• The hybrid work model provides flexibility, enabling a healthy work-life balance.
• You will join a supportive and collaborative team environment dedicated to advancing cardiovascular health through innovative research.
• The role offers the chance to work on impactful clinical trials and gain valuable experience within a reputable pharmaceutical organization located in Tembisa, Gauteng .