sponsor dedicated cra.

Some of the advantages you can expect from your role as a Sponsor dedicated CRA are:

• A competitive compensation package is provided
• Consistent workload
• Career development opportunities 

The Sponsor dedicated CRA will work independently on site, remote and risk based monitoring of  clinical trials. Establish  delivery of site qualification visits, start up activities, driving recruitment and ongoing maintenance including delivery of key study milestones, DBLs through to close out of sites

Primary Responsibilities

• Perform site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance.
• Routinely review the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconcile contents of the ISF with the Trial Master File (TMF). Ensure the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enter data into tracking systems as required to track all observations, ongoing status and action items to resolution.
• Understand project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.

The following qualifications will make you the ideal candidate for the Sponsor dedicated CRA role:

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
• Previous CRA experience gained from a Pharma or CRO.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Strong organisation & prioritisation skills required to balance the needs of multiple protocols. Strong communication /interpersonal skills together with ability to demonstrate critical thinking skills, working with key stakeholders to provide solutions.
• Experience of technologies such as Rave, Veeva Vault, CTMS platforms
• Effective time management to ensure project deadlines are met
• Ability to manage required travel on a regular basis

• Attention to detail
• Critical thinking skills
• Advanced organizational and planning skills

1-2 years

If this sounds like you, we want to hear from you today! Should you need additional information 

please contact me Dora Tzevelekou at 2166001387.

Please note that after the screening of all the CVs received, we will only contact the candidates who meet the requirements of the job to arrange an interview. All applications are considered strictly confidential.