Heads, a global CRO, is seeking a Clinical Research Associate (CRA) based in Spain 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 Companys 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:
-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 drugs 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:
-Prepares reports to document all discussions, measures and actions made during a monitoring visit, telephone contact or remote monitoring. The CRA also sends summary of these reports to the Investigators
-Participates in study specific conference calls and meetings to review progress of ongoing clinical trials; provides feedback to the CRA Manager
-In case of an audit or regulatory inspection, the CRA is responsible for informing and preparing the Site and facilitating the procedure. The CRA works with the appropriate study team members and Quality (QA) in order the corrective actions are in place and performed as soon as possible
-Collaborates