- SOUTH STAFFORDSHIRE - FULL TIME
DATA COORDINATOR
Closing date for applications: 11 June 2022
MAC is a full-service global Contract Research Organisation (CRO). We also own a network of research sites. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health.
We are seeking to appoint a Data Coordinator to join our team and make a positive impact in a growing and progressive CRO. You will be joining a company that put the needs and wellbeing of their people first, who are inclusive and who deliver exceptional service – together.
This role is based at our Cannock Clinic, with travel to MAC sites as required.
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 RESPONSIBILITIES:
Co-ordinate and manage all administrative aspects of arranging study subject appointments in line with protocol schedules, whilst promoting appositive 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
DATA QUALITY
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
Be courteous and sympathetic to all study subjects.
Ensure a welcoming and clean, safe, and pleasant environment for study subjects.
Ensure that study subject results are sent to the GPs as appropriate.
Promote a positive image of MAC Clinical Research to study subjects and customers.
Accept criticism from customers as an opportunity to improve.
Liaise with monitors and ensure their queries are dealt with correctly and in a timely manner.
WORKING AS A TEAM
Recognise the importance of other team members’ roles and skills.
Support and be aware of the workload of others and provide assistance as necessary.
COMMUNICATION
Highlight issues to the attention of the senior personnel as necessary to assist in the smooth running of the site.
Participate in regular meetings with colleagues and customers.
Deal with telephone and email enquiries / communications in a timely manner.
Ensure that any messages are relayed to the appropriate member of staff.
LEADERSHIP
Set a positive example to all colleagues.
Share experience and knowledge with team members.
Take responsibility for ensuring that data quality is maintained at a high level.
Accept ownership of problems.
Assist in the training and development of junior members of staff.
PLANNING AND ORGANISING
Plan and correctly prioritise workload.
Promote and expedite scheduling of study subjects from initial contact.
Monitor own workload to meet priorities.
Develop ideas for improving systems within the site.
Provide information as required to customers and senior personnel to meet requested timescales.
Ensure study paperwork and CRFs are available.
PROFESSIONAL
Seek opportunities for self-development.
Understand the requirements of GCP and work
COMMERCIAL AWARENESS AND CONTRIBUTION TO TARGETS
Be aware of study targets and progress towards achieving them.
CONFIDENTIALITY
Understand requirements for study subject and commercial confidentiality.
Plan work practices to maintain study subject and customer confidentiality
GENERAL
Compliance with MAC health and Safety policy
Compliance with MAC policy on equality and diversity
To maintain professional qualifications required for the role, including continuous personal development
To work to the requirements of SI 2004 no 1031 and amendments thereof, which includes Good Clinical Practice
To work according to MAC SOPs, guidelines and policies
To work according to current data protection standards and practice good information management. Maintenance of strict confidentiality of study subject and business-related data.
To maintain a high level of initiative and personal responsibility, liaising appropriately with team members and managers to ensure your job role is efficiently carried out
To support the aims of MAC and to represent MAC appropriately in a professional way to all our customers
KEY REQUIREMENTS:
Adequately qualified, as determined by Line Manager, through experience or qualification.
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 long service)
Your birthday off work
Regular hours (including Christmas Day, Boxing Day and New Year’s Day off)
MAC Clinical Research invites applications from highly motivated candidates, with a desire to achieve their full potential. You will be working within 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.
Salary: Competitive + Negotiable £ Apply Now
