Clinical Research Coordinator II
On-site · Exton, Pennsylvania, United States
Job Summary
Clinical Research Coordinator II at Clinical Renal Associates in Exton, PA will lead site-level clinical research operations, including patient screening, consent, and enrollment under the principal investigator. Responsibilities include recruiting eligible patients, coordinating with clinic leadership and central Enrollment teams to meet referral and enrollment targets, preparing for monitoring visits, maintaining source documents, and ensuring data accuracy per ALCOA. The role requires maintaining protocol adherence, organizing subject visit plans, coordinating with site administration for resources, reporting adverse events, and managing Investigational Product accountability. Qualifications emphasize experience in clinical research, knowledge of GCP and regulatory requirements, ability to perform basic clinical procedures (blood work, vitals, ECG), data collection and CRF completion, and strong communication skills; bilingual (Spanish) is preferred.
Required Qualifications
- PROFESSIONAL nursing? - not applicable
- Minimum 3-5 years clinical research experience
- Bachelor’s degree in health-related field preferred
- Knowledge of GCP and regulatory requirements
- Good Clinical Practice (GCP) and ICH guidelines
- Ability to obtain informed consent per ICH/GCP
- Bilingual preferred (Spanish)
- Ability to perform basic clinical procedures (blood work, vitals, ECG)
- Excellent interpersonal and communication skills
- Flexibility and organizational skills
- Experience with CRFs and data entry
- Understanding of IRB/Sponsor/monitoring reporting requirements
Desired Qualifications
- Bachelor’s degree preferred
- MA Certification preferred
- Bachelor’s degree in health-related field preferred
- Good Clinical Practice and/or ITIA Certification preferred
- ACRP or Socra Certification preferred
- Bilingual preferred (Spanish)
- Minimum 3 to 5 years clinical research experience
- Knowledge of medical terminology/research
- ECG proficiency
- Ability to multitask in high-volume studies
- Flexibility and strong organizational/communication skills
- Knowledge of GCP, IATA and FDA regulations
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