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Freelance CRA, Poland

Employer
Proclinical Staffing
Location
Homeworking
Salary
EUR60 - EUR70 per hour
Start date
29 Nov 2022
Closing date
13 Dec 2022

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Job Details

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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#CRODelivery

Company

At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.

 

Company info
Website
Telephone
0800 988 4437
Location
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom

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