Clinical Research Quality Coordinator

Provides ongoing remote clinical monitoring assistance to study sites.

Provides ongoing monitoring and review of safety reporting as follows, but not limited to: review of all adverse events documented by site CRAs into the study database/eDES; review of all reporting of SAE via eDES, Medwatch Report Forum, and Pharmaceutical documents, and provide assistance as needed.

Safety reporting to Sponsor, Protocol Chair, Protocol Team, Operations Center PI, Medical Monitor, DSMB, Study sites, and other protocol-designated agencies into eDES, along with email prompts for delinquent data entries.

Provides monitoring review of all newly screened and potential study participants.

Provides ongoing protocol training/support to clinical sites.

Monitors and reviews all central evaluations and sends evaluations to study sites and summarizes protocol requirements as needed.

Collects all external IND safety reports.

Obtains Operations Center Pl's written acknowledgement.

Obtains Protocol Chair's written acknowledgement.

Maintains a safety log of all received safety reports and specifies when protocol and/or consent document changes are required.

Shares all external IND safety reports with clinic study sites after obtaining the Protocol Chair's written acknowledgement.

Places all external IND safety report email communication to clinical sites into eDES study‑specific docs section folder.

Works with the regulatory specialist whenever changes to the informed consent document are required. Plexiform QOL review and site queries.

Reviews diary drug compliance documents and generates queries when necessary. NF Consortium email requests for assistance (potential subjects). Protocol Reviews participate in all protocol reviews and editing if needed. Travel to sites/travel expected 1 to 2 times per month for an average of 1-2 days per monitoring visit or 1 week per month.

Follows the QAC Guidelines for site monitoring. Remote Monitoring - since COVID, remote monitoring.

Provides recommendations of notes to files, provides documentation, and is available for internal audits.

Handles protocol clinical queries by sites and delinquent queries to the site for missing data.

Reports to the QAC Chair as appropriate.

Drug accountability, maintenance, and compliance overall study and final study reports.

Coordinates with Pharmacy for drug compliance. Keep up-to-date database clinical records.

Performs other duties as assigned.