Clinical Research Associate
Next Code Placement
About the Role
- This is a full-time, on-site position for a Clinical Research Associate (CRA).
- Location: Texas, United States.
Key Responsibilities
- Monitor clinical trials.
- Ensure compliance with study protocols.
- Support the quality and integrity of clinical research.
- Conduct clinical trial site visits.
- Review study documentation.
- Verify source data.
- Monitor patient recruitment and enrollment.
- Ensure clinical trial activities follow approved protocols.
- Work closely with clinical investigators, research coordinators, sponsors, and other study team members.
- Identify protocol deviations.
- Document monitoring findings.
- Follow up on corrective actions.
- Help ensure participant safety and data quality.
- Communicate regularly with clinical research sites and cross-functional teams.
- Address study-related issues.
- Maintain compliance.
- Support timely completion of clinical trials.
Requirements & Tech Stack
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Biology, Biochemistry, Public Health, or a related field.
- Strong understanding of clinical trial protocols, study documentation, and Good Clinical Practice (GCP) guidelines.
- Familiarity with applicable FDA regulations and clinical research requirements in the United States.
- Experience reviewing clinical trial documents.
- Experience verifying source data.
- Experience maintaining accurate study records.
- Knowledge of informed consent procedures, adverse event reporting, protocol deviations, and participant safety requirements.
- Proficiency in Microsoft Office, particularly Excel, Word, and PowerPoint.
- Excellent written and verbal communication skills.
- Strong organizational and time-management skills.
- Ability to manage multiple studies, deadlines, and priorities.
- Ability to collaborate with investigators, research coordinators, sponsors, and cross-functional teams.
- Strong problem-solving skills.
- Ability to identify and escalate study-related issues.
- Ability to work full-time on-site in Texas, United States.
- Ability to travel to clinical research sites as required.
Preferred Qualifications
- Master’s degree in Clinical Research, Life Sciences, Pharmacy, or a related discipline.
- Experience in clinical research, clinical trial monitoring, clinical trial coordination, or a related healthcare research role.
- Familiarity with electronic data capture (EDC) systems, clinical trial management systems (CTMS), and electronic trial master files (eTMF).
Entry-Level Considerations
- Qualified recent graduates may be considered for entry-level clinical research opportunities.
- A Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, Biology, Biochemistry, Public Health, or a related field.
- Relevant internships, academic research projects, clinical placements, or experience supporting clinical studies.
- Foundational understanding of clinical research processes, clinical trial protocols, and GCP principles.
- Familiarity with informed consent documentation, research data collection, and study record management.
- Basic knowledge of clinical trial regulations, patient safety, and research ethics.
- Strong documentation skills.
- Excellent analytical, organizational, and problem-solving abilities.
- Willingness to learn clinical trial monitoring procedures.
Preferred Certifications
- ACRP Certified Clinical Research Associate (CCRA)
- SOCRA Certified Clinical Research Professional (CCRP)
- ICH-GCP training
- Other relevant clinical research certifications.