Clinical Research Coordinator II Job Description Template
Our company is looking for a Clinical Research Coordinator II to join our team.
Responsibilities:
- recruiting and consenting study participants;
- creating and maintaining regulatory documentation;
- ensuring protocol adherence and patient study eligibility;
- ensuring specimens/tests/procedures are obtained and conducted per protocol;
- conducting routine internal monitoring of clinical studies;
- assisting the PI in monitoring and reporting of AEs/SAEs/protocol deviations.
Requirements:
- Understanding of medical terminology and clinical trials required skills required;
- 2+ years of Phase I clinical research experience;
- Certification by the Association of Clinical Research Professionals or Society of Clinical Research Administrators;
- Minimum of 2 year experience in clinical research;
- Experience in study protocol documents and SOPs; working with Project Management teams; timelines;
- Proficient in study start up processes; Initiation of the Clinical Research Competency Program;
- Basic knowledge of computer and programs (e.g. Microsoft Word, Excel);
- Knowledge of drug development process, ICH guidelines and GCP;
- Associates degree or equivalent work related experience; BA/BS preferred.