Overview
Veeda Lifesciences is seeking a Clinical Research Associate (CRA) based in Italy 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 / SAEs
Checks 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 patient
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 with the CRA Manager and Clinical Operations Manager to develop feasibility evaluation questionnaires, contact the Investigators to collect feasibility-related information, perform site screening and selection
Supports financial issues of the study, including Investigators' payments
Manages timely subject enrolment and quality data collection
Ensures that procedures are in place for appropriate optimization of patients into the study : evaluates patients' recruitment and determines if it is according to the operational plan & patients' target
Closes down study sites on completion of the trial
Participates in departmental planning sessions, and SOP development, if required
Provides coaching, mentoring and management to the newly appointed and / or inexperienced CRAs to ensure that their role and contribution is optimized
Job Requirements
Bachelor's and / or master's degree (preferably in Health Sciences)
Certified CRA
Previous Work Experience :
6-12 months' work experience as a CRA
Excellent command of English and Italian both oral and written
Attendance of an ICH GCP training course (desirable)
Good computer skills
Good general communication skills
Good organizational skills
Ability to work independently and be a good team player at the same time
Ability to communicate diplomatically, but also effectively with study Site personnel
Ability to deal adequately with stressful situations, flexible timelines and work pressure
Ability to maintain complete overview and deal with several issues at the same time
Ability to work according to specific SOPs, guidelines, regulations & ethical principles in the daily practice
Ability for frequent international and local travelling, including evenings and overnight stays
Join us to be part of a multidisciplinary team of highly skilled scientists and healthcare professionals in the forefront of Clinical Research within a friendly work environment.
Competitive remuneration package comes on top.
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