• SOUTH STAFFORDSHIRE - FULL TIME

STUDY COORDINATOR

Closing date for applications: 31 May 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 Study 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 in our Cannock clinic in South Staffordshire with travel to MAC sites as required.


THE FOCUS OF THE JOB

  • To gain experience of the clinical trial process and become proficient in all aspects of clinical trial coordination

  • To carry out clinical trial procedures in accordance with ICH GCP.

KEY REQUIREMENTS

  • RGN / RMN or BSc Nursing

  • BSc Biomedical science or equivalent related field

KEY RESPONSIBILITIES

Clinical Activities:

  • Perform primary coordinator role on specific clinical trials.

  • Carry out all clinical tasks efficiently and effectively and as per protocol.

  • Display a sound and thorough knowledge of the protocol.

  • To be the primary point of contact for specific study related queries.

  • Display sound organisational skills and the ability to prioritize own workload.

  • Review patient source notes in relation to study inclusion / exclusion criteria.

  • Effectively delegate study procedures to the clinical team.

  • Assist in the scheduling of patient visits as per protocol.

  • Set up and maintain all study related documentation including all site files.

  • Monitor and appropriately report AE’s / SAE’s.

  • Ensure that all patient visits are completed in accordance with the protocol.

  • Monitor clinical supplies and IMP and initiate resupply where required.

  • Develop clinical rating skills

  • To attend all study related meetings where requested.

  • To provide lead study coordinator role where appropriate

Patient and Customer Care:

  • Welcome patients into the clinic and optimize patient experience.

  • Prioritize and promote patient safety.

  • Deal courteously and professionally with patients and customers at all times.

  • Ensure a pleasant and safe environment for all visitors to the clinic.

  • Provide encouragement, education and support to patients and trial subjects.

  • Ensure patients fully understand procedures and encourage them to express any concerns.

  • Communicate efficiently and professionally with the rest of the clinical team to ensure optimal patient care.

  • Deal with complaints in accordance with company policies

Laboratory:

  • Set up of the laboratory files in preparation for study commencement.

  • Ensure laboratory files and logs are updated and complete.

  • Assist with laboratory procedures including, sample processing and packing (appropriate training and IATA certification required).

  • Ensure detailed and accurate specimen labelling and logging.

  • Ensure the monitoring and supply of study specific blood kits.

  • Ensure that company policy is adhered to in terms of relevant Health and Safety issues.

Pharmacy:

  • Dispense medications via study specific method e.g. IVRS / IWRS.

  • Ensure that all Investigational Product is logged, stored and disposed of as per protocol.

  • Maintain accurate drug accountability logs.

  • Maintain accurate daily room temperature and fridge / freezer logs.

Data Management:

  • Ensure the maintenance of all study related documentation including Investigator Site File (ISF), Pharmacy file and patient documentation in accordance with ICH GCP.

  • Ensure meticulous recording and transcription of data in both clinical and research notes.

  • Ensure accurate and complete data is entered into source notes, case report forms and electronic data systems, including monitoring the accuracy of data entry by other members of staff.

  • Ensure timely resolution of data queries.

  • Work closely with the study monitor to resolve any data issues.

  • Where delegated, assist with the preparation of the source documents prior to study commencement.

Recruitment:

  • Maintain an awareness of recruitment issues and deadlines.

  • Promote and assist in recruitment activities where required.

  • Promote patient retention by providing support and regular communication with the study patients

  • Ensure that telephone calls are dealt with professionally and sensitively, whilst projecting a positive image of MAC.

Commercial awareness:

  • Monitor and support site quality as per Company SOPs.

  • To be proactive in implementing company strategy and plans.

  • To support the aims of MAC and represent the company appropriately and professionally to all of our customers.

Professional and Self Development:

  • Maintain and regularly update personal professional development portfolio (NMC and MAC training file).

  • Train other staff in any appropriate areas of competency / expertise where required.

  • Provide practical help and guidance to other members of staff.

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 patient 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

PHYSICAL, WORK ENVIRONMENT, TRAVEL DEMANDS:

  • Potentially long periods standing.

  • Dealing with bodily fluids.

  • Long periods looking at a computer screen.

  • Meeting deadlines and working within strict timelines.

  • Ability to travel between sites if required.

  • Ability to travel to national / international meetings.

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.

Job Description - Study Coordinator 1 V3
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Salary: Competitive + Negotiable £ Apply Now

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