Conduct site management and data monitoring of assigned clinical sites. Ensure that all activities are conducted in accordance with applicable Good Clinical Practices (GCP) and Standard Operating Procedures (SOP).
- Conduct site selection visits to ensure that the facilities and staff are adequate for conducting studies.
- Conduct site initiation visits to ensure sites and study staff are adequately trained and prepared to conduct the study.
- Verify that the research site investigator(s) and study personnel are conducting the study according to the study protocol, GCPs, and regulatory requirements to ensure protection and ethical treatment of human subjects.
- Perform monitoring activities per the monitoring plan (e.g. verification of source documents, informed consent review, site communications, follow up on data anomalies, etc.).
- Review accuracy and completeness of site records (i.e., essential documents, query resolution, and other study documents).
- Ensure complete reporting and proper documentation of monitoring activities.
- Perform other duties as assigned.
Education and Experience
Bachelor’s degree, preferable in science or in a related field. 3 years of previous CRA or advanced clinical data experience. Real world evidence or phase IV experience preferred. Experience in GI or Immunology preferred.
Knowledge, Skills, and Abilities
Excellent knowledge of Good Clinical Practice (GCP) in conduct of clinical studies. Excellent written and verbal communication skills. Excellent Microsoft Office skills as well as computer data acquisition and report writing. Ability to interact with all levels of internal and external contacts. Ability to independently set and manage multiple priorities. Ability to demonstrate advanced judgment and decision-making ability in the execution / oversight of study sites.
This is an office-based position. Most monitoring activities are completed remotely, however occasional travel may be required.