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Job Brief
We are seeking an experienced and detail-oriented Clinical Research Associate to join our research team. A Clinical Research Associate plays a key role in the planning, monitoring, and evaluation of clinical trials. The ideal candidate will oversee the execution of clinical trials, ensure compliance with regulatory standards, and contribute to the advancement of medical research.
Responsibilities
- Oversee study sites and activities to ensure compliance with industry protocols and study terms.
- Collect, authenticate, and manage case report forms and other study documentation.
- Screen potential study participants through medical record reviews, interviews, and coordination with healthcare providers.
- Coordinate with ethics committees to protect the rights and safety of research subjects.
- Maintain comprehensive records, including regulatory forms, drug dispensation, and consent forms.
- Prepare and review final reports, manuscripts, and applications such as NDAs and BLAs.
- Ensure accurate transmission of clinical data to data management centers and resolve any data-related issues.
- Supervise research staff, including training, hiring, and performance management.
- Review and approve study-related documents, including informed consent forms.
- Act as a liaison between study sites, sponsors, and regulatory agencies, ensuring compliance with local and federal regulations.
Requirements and Skills
- Bachelor’s degree in pharmacy, nursing, or a related field.
- At least 2 years of experience in clinical research or a similar role.
- Knowledge of regulatory requirements and guidelines, including GCP and ICH.
- Certification in clinical research, such as from the Association of Clinical Research Professionals (ACRP), is preferred.
- Proficiency in clinical trial data management systems and electronic data capture.
- Strong written and verbal communication skills.
- Excellent attention to detail and accuracy in data management.
- Superior problem-solving and decision-making skills, with the ability to manage multiple tasks effectively.
- Advanced organizational and planning skills, with experience in site selection and monitoring.
- Proficiency in MS Word and Excel, with a strong understanding of laboratory procedures and equipment.
Frequently Asked Questions
What does a Clinical Research Associate do?
A Clinical Research Associate oversees trial progress, manages data collection, ensures compliance with regulations, and coordinates with stakeholders to facilitate successful research studies.
What should you look for in a Clinical Research Associate resume?
When reviewing a Clinical Research Associate resume, consider:
- Relevant Experience: Look for prior experience in clinical research, including specific roles such as CRA, clinical trial coordinator, or research assistant. Experience should ideally include monitoring, managing, and coordinating clinical trials.
- Educational Background: Check for a relevant degree (e.g., in pharmacy, nursing, or life sciences). Certifications such as those from the Association of Clinical Research Professionals (ACRP) or similar organizations are advantageous.
- Regulatory Knowledge: The resume should demonstrate familiarity with regulatory requirements and guidelines such as Good Clinical Practice (GCP) and International Council for Harmonization (ICH).
- Technical Skills: Look for proficiency in clinical trial data management systems and electronic data capture (EDC) systems. Experience with statistical data collection and analysis techniques is also important.