Scra (Remote)

KPS life is looking to recruit SCRA to join our team on permanent bases. Full time position, remote, Italy.

The primary responsibility of the Senior Clinical Research Associate (Sr. CRA/SCRA) is to provide monitoring expertise to each Sponsor study they are assigned. The Sr CRA will perform all the tasks related to monitoring and ensuring clinical studies are being performed in accordance with the Sponsor protocol and GCP ICH guidelines. The Sr CRA will act as the site’s main source of information and performance manager. The CRA will provide support, training, and study procedure knowledge to the sites and study teams to ensure successful conduct and completion of the sponsor’s study.

The Sr CR/SCRA A will:

• verify that the investigator(s) and study personnel are conducting the study according to the protocol, “Good Clinical Practices”, and regulatory requirements to ensure protection and ethical treatment of human subjects.
• perform all required monitoring visits as per the monitoring plan to include: Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close Out Visit (COV).
• ensure identification and reporting of safety issues, when applicable, from research site staff to the sponsor and the IRB/IEC.
• perform monitoring activities per the monitoring plan (e.g. verification of source documents and eCRF/CRFs, site communications, follow up on data anomalies, etc.).
• review accuracy and completeness of site records (i.e., essential documents, query resolution, and other data collection tools).

• ensure accountability of Investigational Product and related supplies are performed, when appropriate.
• ensure the site is identifying issues and implementing corrective and preventive actions to ensure inspection readiness.
  • responsible for creating, generating and providing confirmation letters and follow up letter to the Principal Investigator and site for each visit.
• follow study protocol and procedures while ensuring the quality completion of the clinical study.
• ensure information is communicated and conveyed to the study team as it pertains to their assigned sites and studies.
  • escalate any site issue to the Lead CRA and/or study team, as needed.
  • ensure that training and applicable Sponsor information and/or materials are completed for their position.
    • produce monitoring reports in accordance with the monitoring plan and required submission timelines.
    • ensure compliance with quality standards (SOPs, ICH, GCP etc.).
    • develop in-depth knowledge in relevant indications and clinical study methodology.
    • perform any other task assigned by direct manager.

The Sr CRA/SCRA will have:

• in-depth knowledge of clinical drug development processes and experience applying GCP, ICH and FDA requirements.
• solid knowledge of clinical research study processes; ability to incorporate and adhere to GCP and regulatory standards.

• strong communication skills to be able to discuss with the Principal and Sub-Investigators and their site staff, even in challenging situations such as recruitment, protocol deviations and oversight.
• strong organizational skills.
• strong motivational skills.
• the ability to perform issue escalation through resolution.
• flexibility and be able to work with deadlines.
• the ability to operate independently as well as be a Team Player.
• a solution-oriented and problem-solving attitude.
• onco-hematology experience is a must

The Sr CRA/SCRA:

• will have life science degree
• will have at least 4 years of clinical monitoring experience.
• will have at least 6 years of experience in the pharmaceutical industry or clinical research site-based experience.
• will have knowledge of ICH GCP guidelines.
• will have the required therapeutic area experience.
• must be able to travel (estimated at 60%-70% per week).
• system experience preferred (i.e. CTMS, eDC, eTMF etc.)