At a Glance
- Tasks: Oversee clinical trials, ensuring compliance and data integrity while building strong relationships.
- Company: Leading pharmaceutical company dedicated to innovative patient care.
- Benefits: Competitive salary, health insurance, retirement plan, and generous paid time off.
- Other info: Flexible hybrid role with opportunities for professional development and career advancement.
- Why this job: Make a real impact in healthcare while advancing your career in a supportive environment.
- Qualifications: Bachelor's degree in Life Sciences and 4+ years as a Clinical Research Associate.
The predicted salary is between 69300 - 84700 $ per year.
About the Role
Our client, a distinguished pharmaceutical company committed to advancing patient care through innovative research, is seeking an experienced Senior Clinical Research Associate (CRA) to join their dedicated clinical operations team in Kimberley, Northern Cape .
This role is vital for overseeing and managing clinical trials at investigator sites, ensuring adherence to protocols, Good Clinical Practice (GCP), and regulatory requirements.
You will be instrumental in maintaining the integrity and quality of trial data and contributing to the successful completion of clinical development programs.
This hybrid role balances essential on-site site visits with remote administrative tasks, offering flexibility within Kimberley, Northern Cape .
Key Responsibilities
- Conduct site initiation, monitoring, and close-out visits according to study protocols and standard operating procedures (SOPs).
- Ensure the quality and integrity of clinical trial data by verifying source documents against case report forms (CRFs).
- Monitor subject recruitment and retention efforts at investigator sites.
- Ensure compliance with all applicable regulatory requirements, GCP, and study protocols.
- Build and maintain strong relationships with investigators, site staff, and study sponsors.
- Manage investigational product accountability and dispensing records.
- Oversee site readiness and provide training to site personnel on study-specific procedures.
- Prepare and present monitoring visit reports in a timely manner.
- Identify and elevate potential issues, risks, and discrepancies to the Clinical Trial Manager and other relevant stakeholders.
- Participate in study team meetings and contribute to the overall success of clinical trials.
Requirements
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field.
- Minimum of 4 years of experience as a Clinical Research Associate (CRA) or in a similar clinical trial management role.
- Thorough understanding of clinical trial processes, ICH-GCP guidelines, and relevant regulatory requirements.
- Proven experience in conducting site monitoring visits and documenting findings.
- Excellent understanding of medical terminology and clinical trial documentation.
- Strong organizational, time management, and problem-solving skills.
- Exceptional interpersonal and communication skills, with the ability to build rapport with diverse stakeholders.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to travel to investigator sites as required.
- Self-motivated with the ability to work independently and as part of a remote or hybrid team.
Benefits
Our client offers a competitive salary package commensurate with experience, along with comprehensive benefits including health insurance, a retirement annuity, and performance-based bonuses.
Opportunities for professional development, ongoing training, and career advancement within the clinical research field are provided.
Employees also receive generous paid time off and access to wellness programs.
This role in Kimberley, Northern Cape , offers a stimulating career path within a supportive and innovative pharmaceutical research environment.
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Senior Clinical Research Associate in Kimberley employer: Placements24
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