• MAC

SOURCE DOCUMENT COORDINATOR


Closing date for applications: 31 May 2021

MAC Clinical Research manages clinical trials for the pharmaceutical industry and we are seeking to appoint a Source Document Coordinator to join our team and make a positive impact in a world-leading Clinical Research Organisation.


This role is temporary for a fixed term of 12 months, with potential to be made permanent.


We are happy to be flexible with regards to location in the UK, so any of our clinical sites may be considered with the flexible option of home working.


This role would suit candidate with clinical research background or keen interest source document management/data management in a Clinical Site or CRO environment.


The focus of this role is to act as a central point of contact for creating and updating source documents for all clinical trials run by MAC Clinical Research, across Late and Early Phase, ensuring the source documents capture the study requirements and are consistent with the study protocol, eCRF, other study manuals and site procedures. This includes on occasions contacting the Sponsor/CRO directly to clarify protocol queries and working across the clinical teams.


KEY RESPONSIBILITIES:

  • Prioritise and monitor workload to ensure the correct studies are being focused on at the correct time.

  • Liaise with all sites as required ensure documents are ready for visits and work with the source document team appointed appropriately for each study.

  • Identify quality problems and recommend solutions.

  • Assist in harmonization of processes across all MAC sites.

  • Review and check quality of documents.

  • Work with colleagues to ensure corrections and updates are completed appropriately.

  • Develop ideas for improving systems within the company.

  • Liaise effectively and positively with staff of both Early Phase and Late Phase.

  • Bringing issues to the attention of the relevant staff and managers.

  • Support and be aware of the workload of others.


KEY REQUIREMENTS:

  • Excellent oral and written communication skills.

  • Self-motivated with the ability to work with minimal supervision.

  • Demonstrates a sound knowledge of ICH GCP.

  • Strong planning, organisational and time management skills.

  • Strong analytical and problem-solving ability.

  • Understanding of the importance of study protocols and the ability to interpret.

  • Understand how to capture required data.

  • Able to always meet deadlines.

  • Understanding and experience of the eCRF data capturing systems (desired).

  • Strong computer skills (especially Microsoft Package).


BENEFITS:

  • Competitive salary in keeping with pharmaceutical industry standards and will reflect experience

  • Free onsite parking

  • 25 days annual leave plus bank holidays (increasing in increments to 30 days after 6 years service)

  • Your birthday off work

  • Regular hours (including Christmas Day, Boxing Day and New Years Day off)


MAC Clinical Research invites applications from highly motivated candidates, with a desire to achieve their full potential. You will be working with an organisation that sees you as an investment and is keen for you to achieve your career aspirations.


Please note that if we receive a high volume of applications this date may be brought forwards.


Job Description - Source Document Coordi
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• 130KB

Salary: Competitive + Negotiable £ Apply Now

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