Oversees the progress of clinical investigations by conducting pre-study, initiation, interim and close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices. Works closely with the Clinical Project Manager to ensure all monitoring activities are conducted according to study requirements.
- Participates in the investigator recruitment process. Performs initial qualification visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study, both clinically and technically.
- Assists in the preparation and review of protocols, eCRFs, study manuals, and other study documents as requested.
- Obtains and reviews regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials including submission if required
- Performs study initiation activities; reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF.
- Conducts periodic site file audits to ensure compliance with GCPs and accuracy of Trial Master File aAssures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Prepares monitoring reports and letters in a timely manner in accordance with the study monitoring plan.
- Performs investigational product inventory. Verifies destruction of unused materials or ensures return to designated location, as required.
- Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries.
- Serves as primary contact between Karyopharm and investigator Participates in study team meetings providing monitoring updates.
- Assists with, attends, and may present at Investigator Meetings for assigned studies.
- Performs study close-out visits.
- May request site audits for reasons of validity.
- Performs other duties as requested.
- Up to 75% domestic and/or international travel may be required.