Clinical Research Associate

Job Description: Clinical Research Associate
Title: Clinical Research Associate
Position type: Permanent, Full time
Location: Flexible, home-working within UK or at P1vital Products Ltd offices in Wallingford
Reports to: Project Manager

Role and responsibilities:
We have an excellent opportunity for an enthusiastic and motivated individual wanting to progress their career as a Clinical Research Associate (CRA) in the medical monitoring of clinical trials. P1vital Products Limited (PPL) is a leader in developing software and products for the pharmaceutical and healthcare sectors. Reporting to the Project Manager, the Clinical Research Associate will be responsible for supporting key clinical studies utilising medical devices in the field of neuro-psychiatry. Provision of project administrative support of associated clinical studies will also be required. Key responsibilities of this role comprise:

Clinical Monitoring
• To support the set-up of study sites, including ensuring each site has the necessary study materials and other resources to conduct the study
• To develop and maintain strong working relationships with site investigators and study site staff, promoting study recruitment strategies.
• To support and conduct study monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and protocol compliance.
• To conducts source document review of appropriate site source documents and medical records.
• To verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrate diligence in protecting the confidentiality of each subject/patient.
• To verify that data entered into CRFs, eCRF, ePRO and/or other platforms are consistent with paper
source and electronic source document, and to verify overall site compliance with electronic data
capture requirements
• To apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
• To use judgment and experience to evaluate overall performance of site and site staff and to provide
recommendations regarding site-specific actions including the immediate communication and/or escalation of serious issues to the project manager and co-develop action plans.
• To review on regular basis throughout the study conduct the Investigator Site File for completeness
and ensure the site is filing all documents on an ongoing basis to be inspection ready
• To check site delegation list is always up-to-date and signed off by the PI and that any new staff member has received adequate training prior to their involvement in the study
• To write study visit reports and status reports
• To file and collate study documentation and reports
• To support the close-out of study sites and archive study documentation and correspondence.
• Throughout, to maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.

Clinical Project Administration
• Set up and maintain project documentation repository filing and storage.
• Provide project administrative support to the project manager for assigned clinical trials to enable efficient tracking, documenting, and reporting of project meeting discussions via minute-taking and capture of associated action items.
• Track and distribute actions in Action and Decision log.
• As required, assist the Project Manager(s) in the production and maintenance of project plans, risk and
issue logs and/or project summary reports.

Skills and experience
• Graduate with life sciences or equivalent degree
• A minimum of 1 year’s prior CRA experience working in a clinical trials
• Knowledge of ICH-GCP
• Excellent communication skills (both written and oral)
• Ability to multi-task and problem solve
• A concern for quality, attention to detail and accuracy
• Good organisational, computer and administrative skills
• Ability to work independently in a fast-paced environment
• Proactive contribution towards the team by being a flexible team player

If you are interested in finding out more about this position, or to apply, please email your CV to dmays@p1vital.com