Study Start-up Associate/CTA/CRA

2/2020 – 4/2021

- Performed site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance. Used judgment and experience to evaluate overall performance of site and site staff and provided recommendations regarding site-specific actions.

- Verified the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrated diligence in protecting the confidentiality of each subject/patient. Assessed factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.

- Performed investigational product (IP) inventory, reconciliation and reviewed storage and security. Verified the IP has been dispensed and administered to subjects/patients according to the protocol. Verified issues or risks associated with blinded or randomized information related to IP. Applied knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.

- Routinely reviewed the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciled contents of the ISF with the Trial Master File (TMF). Ensured the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
- Documented activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supported subject/patient recruitment, retention and awareness strategies. Entered data into tracking systems as required to track all observations, ongoing status and action items to resolution.

Forschung & Entwicklung

8/2018 – 1/2020

- Set-up, file and maintain of eTMF ans pTMF and may input information into databases for clinical tracking.
- Support regulatory and submission team and updates for investigator sites , studies or project team.
- Process, log and distribute completed case report forms.
- Coordinate completion and execution of contracts, vendor agreements and client information.
- Oversee the work of Clinical Assistants and provide on-the-job training.

Forschung & Entwicklung

1/2016 – 7/2018

- Set-up, file and maintain of eTMF ans pTMF and may input information into databases for clinical tracking.
- Support regulatory and submission team and updates for investigator sites , studies or project team.
- Process, log and distribute completed case report forms.
- Coordinate completion and execution of contracts, vendor agreements and client information.
- Oversee the work of Clinical Assistants and provide on-the-job training.

Forschung & Entwicklung