Clinical Research Associate

Clinical Research Associate# Clinical Research Associate Darmstadt Vollzeit  Kein Home Office möglich

Clinical Research Associate Veeda Lifesciences is seeking a Clinical Research Associate (CRA) based in Germany for its growing international hematology/oncology Clinical Trials program.

This is a full-time job.

Job overview:
The CRA is responsible for ensuring that the conduct of a clinical trial at selected Investigational Sites is according to the currently approved protocol/amendments, ICH GCP guidelines, the applicable Standard Operating Procedures (SOPs) and the applicable laws and regulations.

He/she is the primary responsible person for communication on operational study related activities between the Sponsor, the Investigator and other study personnel to build and maintain successful working relationships.

The most important responsibility is to ensure that the subjects’ rights are respected and that all collected clinical trial data are accurate, complete, and verifiable from source documents.

Main responsibilities:

-Acknowledges, follows& ensures compliance with the Company’s Quality and Information Security Management Systems, ICH GCP guidelines, applicable local and international legislation, including data protection legislation, as well as any amendments or updates the above-In case of deviation from the approved protocol, ICH GCP guidelines and/or applicable legislation during the study conduct, the CRA is responsible for reporting it to the Line Manager and other applicable roles according to SOPs-Conducts pre-study visits at potential investigational sites, to perform the study related feasibility and/or selection activities and evaluate their resources and facilities-Collaborates with the Regulatory Affairs Department and concerned Clinical Operations staff for clinical submissions and contracts respectively for:

Managing Hospital IEC study submissions and approvals with follow through to ensure successful outcome

Preparation of study contracts & relevant files to be submitted for the study financial management acceptance, as required by the applicable local legislation-Fully explains the purposes, set-up, and procedures of the clinical trial to the Investigators and is responsible for training and assisting them in the conduct of clinical trials-Prepares and updates the Clinical Trial Files throughout the study and ensures the proper collection of essential documents and other study-related documents during the trial-Ensures that the Sites are supplied with adequate study medication, verifies that drug accountability is performed correctly and ensures the drug’s safe shipment, storage, dispensing, return and destruction, as applicable-The CRA is responsible for adequate monitoring of the clinical trial conduct at the Investigational Sites (e.g., performs monitoring visits at the Sites) during which he/she:

Ensures Investigators’ knowledge and compliance with the clinical protocol and ICH GCP guidelines

Verifies that Investigators’ qualifications and resources remain adequate throughout the trial period

Reviews and verifies the data reported in the eCRF against source data, according to the monitoring plan which determines the depth and extend of source data verification

Ensures that written informed consent has been obtained from all subjects prior to any study related screening activity or requirement

Fully verifies subject consent procedures against ICH GCP guidelines and legislation

Checks and discusses recruitment and timelines with the Investigators Checks the storage and adequacy of clinical trial supplies

Maintains and updates the Investigator’s Files as required to confirm completeness

Co-ordinates the proper reporting of Safety Information to the Sponsor according to the Safety Reporting Plan, where applicable. CRA is also responsible for making sure that the Investigators are adequately trained in identifying and reporting AEs/SAEsChecks that all submissions, reports, notifications and applications to the IEC/IRB or Regulatory Authorities have been made by the Investigator in a timely manner

Performs drug accountability and ensures the proper dispensing of study drug to the…