Lead Clinical Research Associate

3 weeks ago


Remote, United Kingdom MAC Clinical Research Full time

MAC Clinical Research are looking for a pro-active Lead Clinical Research Associate (LCRA) to join our Clinical Operations department.

If you have a bachelor's degree or equivalent in healthcare or scientific discipline, have at least 5 years of on-site, independent monitoring experience within a UK CRO/SMO, then we want to hear from you.

**FOCUS OF THE JOB**
- Coordinate all activities required for setting up and monitoring a study.
- Monitor studies at allocated sites to ensure quality and compliance with the study Protocol, Monitoring Plan and ICH GCP.
- Complete and submit accurate study status reports to the project team in a timely manner.
- Responsible for maintaining all study monitoring documentation.
- Manage the query resolution process effectively by liaising with the project team and the study site(s).
- Line Management of CRAs as appropriate
- Review and Authoring SOPs/GUIs, templates, forms and project specific documents
- Coordinate data management activities with relevant stakeholders to ensure integrity of the clinical trial data

**KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED**
- A Bachelor's degree or equivalent in a health care or other scientific discipline
- Significant on-site, independent monitoring experience. Preferably, a minimum of 5 years in a CRA role within the Pharmaceutical or CRO Industries.
- Excellent computer skills including use of Microsoft Office.
- Excellent oral and written communicative skills. Fluent in oral and written English
- Excellent time management skills to organise and prioritise workload.
- Able to work independently and proactively.
- Excellent inter-personal skills.
- Ability to lead by example on process development, departmental and project objectives, and overall business strategy and initiatives.
- Ability to work in a collaborative team environment.
- Knowledge of drug development process including the relationship between the CRO industry and Pharmaceutical companies.
- Knowledge of the regulatory framework that surrounds drug development and the clinical trial process.
- Knowledge of clinical trial process; including the interaction between the DM team and clinical operations

**MANAGEMENT**
- Line management and training of allocated CRA’s, and other departmental roles, working on international projects.

**LEADERSHIP**
- Initiate changes in working practices
- Provide practical solutions for problems
- Motivate, encourage and train other members of the CRA team

**BENEFITS**
- Competitive salary in keeping with pharmaceutical industry standards and will reflect experience
- 25 days annual leave plus bank holidays (increasing in increments to 30 days after 6 years long service)
- Health insurance
- Your birthday off work

Closing date: 13 January 2023

**Job Types**: Full-time, Permanent

**Benefits**:

- Company pension
- Private medical insurance
- Work from home

Schedule:

- 8 hour shift
- Monday to Friday

**Experience**:

- UK Clinical Research Associate: 5 years (required)
- independent on-site monitoring: 5 years (required)

Work authorisation:

- United Kingdom (required)

Work Location: Remote

Reference ID: HR157



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