SCRA

A leading Clinical Research Organisation (CRO) is seeking to recruit a Senior Clinical Research Associate to its German-based team. The organisation accelerates the clinical development of orphan drugs and facilitates patient access to urgently needed new treatments for rare conditions. Based in Buckinghamshire, but with plenty of flexibility for working in a home-based capacity, this is an exciting opportunity to work with an internationally reaching organisation.

Job Responsibilities:

• Preparing and conducting initial feasibility activities to identify suitable potential study sites.
• Preparing and conducting site selection and initiation visits, routine monitoring and close-outs, and submitting visit reports and up-to-date site status reports to the Study Team Leader.
• Preparing applications to ethics committees.
• Negotiating contracts with host organisations and local/central laboratories/pharmacy etc.
• Coordinating and being responsible for ensuring completion and provision of approved study documentation e.g. CRFs, patient diaries, study participation cards, Quality of Life forms, etc.
• Assisting in the planning and participating in Investigator Meetings when required.
• Attending study team/sponsor meetings as required.
• Overseeing study site management during the study conduct, training, and re-training site staff as necessary.
• Organising/relaying all needs of study site staff in order to conduct the trial to acceptable standards, ordering and coordinating study supplies as necessary.
• Assisting and supporting the data validation procedure, ensuring data standards are met.
• Providing relevant quality essential documentation to the Trial Master File, reviewing the relevant Study Site Files periodically for accuracy and completeness.
• Performing ongoing review of the Investigator Site Files to ensure the files are kept up to date, maintaining a tracker of the contents.
• Maintaining all electronic documents with appropriate files names according to the company's naming conventions.
• Maintaining adequate level of training, ensuring that all training is completed in a timely manner and documented evidence is filed according to company procedures.
• Participating in audits and inspections when requested to do so.
• Participating in the preparation of audit/inspection responses.
• Participating and contributing to in-house clinical operations meeting.
• Contributing to the quality of the clinical procedural documentation, providing input and feedback to the Quality Assurance Department as a subject matter expert.
• Assisting and supporting the data validation and clean file procedure. Ensuring data standards are met.
• Overseeing the final archiving of all study documentation in-house.

Skills and Requirements:

• Demonstrable experience and/or education in a relevant or similar capacity.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.

• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Julia Tegelmann at +44 203 854 1052 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical Staffing 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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