Freelance CRA, Poland

Proclinical are recruiting a Freelance CRA for an innovative CRO. This role is on a contract basis and allows for remote working anywhere within Poland.

Job Responsibilities:

• Assist in the day to day management and execution of projects assigned.
• Aid in the preparation of project specific
• Continue to keep up on the latest in cancer therapy, clinical trial design and conduct, and good clinical practice.
• Collaborate with other members of the project team to meet Sponsor Protocol and company objectives of Regulatory Readiness
• Create and manage effective routine communications with study sites providing timely study updates and support to sites.
• Ensure site communications are documented and archived as per project requirements and SOPs.
• Establish and maintain effective, routine communications with the internal project team, providing timely project team updates on site related issues.
• Assist in the preparation of the Investigator and Sponsor files with essential documents for the initiation of sites participating in clinical studies.
• Support study staff with maintaining the sponsor files during the life of the study.
• Assist in archiving at the end of study in accordance with relevant SOPs, policies and local regulatory.
• Maintain up-to-date site information
• Perform ongoing management of essential regulatory documentation at the outset and across the lifespan of a study:
• Essential document collection, review, upload, maintenance, and close-out activities, ensuring that that sponsor and investigator obligations are being met and follow applicable local regulatory requirements and ICH/GCP guidelines.
• Complete Site Essential Documentation verification prior to upload into the eTMF.
• Execute quarterly QC of assigned studies/sites in the eTMF according to SOP.
• Implement study tracking via CTMS, investigator site file tracker (if utilized) and/or sponsor designated system to ensure that the study files are current, accurate and complete.
• Ensure protection of subjects, subjects' rights, and the integrity of data through adherence to Good Clinical Practice, applicable regulatory requirements, Standard Operating Procedures, and protocol compliance.
• Participate in the conduct of pre-qualification, initiation, routine monitoring, remote monitoring, and close-out visits in accordance with the relevant SOPs to include but not limited to:
• Source document review and comparison to CRF data
• CRF review/retrieval and data corrections
• IMP accountability
• Maintenance of on-site investigator files
• IEC/IRB documentation
• Local laboratory documentation
• Maintenance of investigational supplies
• Subject consent and consent process review (Informed Consent Form and source documentation)
• Verify patient eligibility
• Assess and document protocol compliance and deviations
• Identification of safety and efficacy issues, with escalation as appropriate, including, but not limited to:
• Serious adverse event reports
• Adverse event reporting
• Treatment failures
• Site visit report preparation within study specific timeframe
• Assist with all aspects of site management as described in the study plans
• Proactively identify and resolve potential site and study issues.
• Identify and escalate data quality issues to ensure clinical data integrity
• Provide support to project management via ongoing project reports and updates.
• May be responsible for supporting multiple studies simultaneously
• Must prioritize appropriately to meet business needs to ensure on-time, quality deliverables.
• Perform other duties as assigned by management.

Skills and Requirements:

• Bachelor's degree (BSc, BA, or RN equivalent) in biological or human science-related field or equivalent experience.
• Successful completion of an approved Clinical Research / Monitoring course
• Previous experience with Clinical Research Site Coordination or related fields (i.e. Regulatory Specialist) preferred.
  Or
• Previous experience in monitoring (i.e. In-House CRA/CTA/CMA) or equivalent experience) preferred.
• Professional attitude with good customer focus.
• Effective communication skills: verbal/written/presentation.
• Good interpersonal skills, including persuasion and influence.
• Able to work independently as well as in a group.
• Good time management, multitasking and execution skills.
• Good organizational skills, including efficiency, punctuality, and collaboration in a team environment.
• Demonstrated proficiency in Microsoft Outlook, Word, Excel and PowerPoint.
• Technically proficient enough to work in a remote environment and able to address minor technical challenges without support but will timely escalate to Information Technology Support for challenges beyond capabilities.
• Capable of absorbing and applying knowledge gained through internal and external trainings on protocols assigned.
• Knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements.
• Effective knowledge of the drug development process and the organizational structure

If you are having difficulty in applying or if you have any questions, please contact Anastasiya Stepovik at +44 203 870 6797.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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