Clinical Research Associate

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

The position is offered on a freelance basis.

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.