Study Coordinator

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 dedicated team in Merseyside.

Please note this is an on-site role based in Merseyside. There will be some flexibility needed to work nights/weekends when required.

FOCUS OF THE JOB:  

To effectively coordinate clinical research trials and gain experience of more technically complex studies. 

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

KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED: 

RGN / RMN or BSc Nursing  

BSc Biomedical science or equivalent related field 

At least 1 year experience as a SC 1 or comparable clinical trials experience 

RESPONSIBILITIES: 

Perform primary coordinator role on specific clinical trials. 

Assist the Clinical Science team with technical procedures where required. 

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 scale skills. 

Develop skills in pre-checking of patient medical histories.

Welcome patients into the clinic and optimize patient experience, whilst promoting patient safety. 

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

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. 

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

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

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. 

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. 

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 

**Benefits**:

- Company pension
- Cycle to work scheme
- Free parking
- Health & wellbeing programme
- On-site parking
- Referral programme
- Sick pay

Schedule:

- Monday to Friday
- Night shift
- Weekend availability

Application question(s):

- Do you require sponsorship to work in the UK (now or in the future)?

**Education**:

- Bachelor's (preferred)

**Experience**:

- Clinical trials: 1 year (required)

Work authorisation:

- United Kingdom (required)

Work Location: In person