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.
Responsibilities
* Acknowledge, follow and ensure 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 to the above.
* In case of deviation from the approved protocol, ICH GCP guidelines and/or applicable legislation during the study conduct, report it to the Line Manager and other applicable roles according to SOPs.
* Conduct pre-study visits at potential investigational sites to perform feasibility and/or site selection activities and evaluate resources and facilities.
* Collaborate with the Regulatory Affairs Department and Clinical Operations staff for clinical submissions and contracts, including managing hospital IEC study submissions and approvals with follow-through to ensure successful outcome; prepare study contracts and relevant files for study financial management acceptance as required by applicable local legislation.
* Explain the purposes, setup and procedures of the clinical trial to Investigators and train/assist them in the conduct of clinical trials.
* Prepare and update the Clinical Trial Files throughout the study and ensure proper collection of essential documents and other study-related documents during the trial.
* Ensure Sites are supplied with adequate study medication, verify drug accountability, and ensure safe shipment, storage, dispensing, return and destruction as applicable.
* Monitor the clinical trial conduct at Investigational Sites, including monitoring visits, to ensure investigators’ knowledge and compliance with the protocol and ICH GCP guidelines; verify that Investigator qualifications and resources remain adequate; review and verify data against source documents; obtain informed consent from all subjects before screening activities; verify consent procedures; check recruitment, timelines, storage and adequacy of trial supplies; maintain Investigator Files; coordinate safety reporting to the Sponsor; ensure investigators are trained to identify and report AEs/SAEs; ensure timely submissions to IEC/IRB or Regulatory Authorities.
* Prepare reports documenting monitoring activities and share summaries with Investigators; participate in study-specific conference calls and meetings; provide feedback to the CRA Manager.
* During audits or regulatory inspections, inform and prepare the Site and facilitate the procedure; work with study team members and QA to implement corrective actions promptly.
* Collaborate with the CRA Manager and Clinical Operations Manager to develop feasibility evaluation questionnaires, contact Investigators to collect feasibility information, and perform site screening and selection.
* Support financial issues of the study, including Investigators’ payments.
* Manage timely subject enrolment and quality data collection; ensure procedures are in place to optimize patient enrollment.
* Close down study sites on completion of the trial; participate in departmental planning sessions and SOP development as required; provide coaching, mentoring and management to newly appointed/inexperienced CRAs to optimize their role and contribution.
Qualifications
* Bachelor’s and/or master’s degree (preferably in Health Sciences).
* Certified CRA.
* Previous work experience: 6-12 months as a CRA.
* Excellent command of English and Italian (oral and written).
* Attendance of an ICH GCP training course (desirable).
* Good computer skills, general communication, and organizational skills.
* Ability to work independently and as part of a team; diplomatic but effective communication with study site personnel.
* Ability to handle stressful situations, adhere to timelines, and manage multiple issues simultaneously.
* Ability to work according to SOPs, guidelines, regulations and ethical principles; willingness to travel internationally and locally, 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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