Early Phase Data Coordinator - ref. l72865303

Good time management skills are must in this busy role, so you’ll need to be able to successfully prioritise your workload to meet deadlines. Adaptability, excellent data entry skills and a keen eye for the details are essential as this role involves working closely with the Study Managers and Medics in relation to study documentation.

The focus of this role is to provide comprehensive data handling support and facilitate with the smooth running of MAC Clinical Research team activities.

KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED:

• 1 year experience in a similar role
• Excel and Word proficient
• Time management
• Ability to communicate at all levels
• Data entry experience

RESPONSIBILITIES:

• Co-ordinate and manage all administrative aspects of arranging study subject appointments in line with protocol schedules, whilst promoting a positive image of MAC Clinical Research, as required
• Responsible for ensuring that clinical trial data across multiple studies is accurate, complete and in line with ICH GCP and ALCOAC principles
• Responsible for ensuring the accuracy of completed clinical trial documents, inclusive but not exhaustive of; essential documents with the ISF, clinical source documents and completed informed consent forms
• Develop, maintain, and produce tools for tracking subject study statuses and provide accurate figures to the project management team.
• Present a positive image of MAC Clinical Research to GP surgeries when contacting them
• Interact with external vendors in order to accommodate receipt of essential source data files/records (central labs, imaging vendors etc.) and ensure internal medic review is completed in timely manner
• Understand and apply protocol criteria
• Enter study subject details on paperwork/systems as necessary
• Attend investigator Meetings and disseminate role specific learnings across all UK sites as required
• Utilise company management system, Envision, to upload source documents as required
• Set up of source notes for the day’s study subjects
• Collaborate with CRAs/internal/external auditors and Site Directors to ensure protocol deviations are appropriately managed, documented and communicated

• Check that all data have been accurately entered in the CRF from the source notes, and that any queries are addressed promptly
• Work with clinic staff to ensure corrections are completed promptly and in line with ALCOAC
• Liaise with monitors to clarify any problem areas
• Ensure that all monitor queries are resolved by the next monitoring visit.
• Ensure a timely response to Data Clarification requests.
• Set up and maintenance of site files.
• Patient and customer care
• Working as a team
• Communication
• Planning and organising
• Professional development
• Commercial awareness
• Strict confidentiality

BENEFITS:

• Competitive salary in keeping with pharmaceutical industry standards that will reflect experience
• Health Insurance
• Free onsite parking
• 25 days annual leave (increasing in increments to 30 days after 6 years' service)
• Your birthday off work

MAC Clinical Research invites applications from highly motivated candidates, with a desire to fulfil 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 email maccareers@macplc.com should you require any special arrangements or reasonable adjustments to be made throughout this selection process. This will enable us to accommodate your request as necessary.

Benefits:

• Free parking
• On-site parking
• Private medical insurance

Schedule:

• 8 hour shift
• Monday to Friday

Work authorisation:

• United Kingdom (required)

Reference ID: HR394