Senior Clinical Research Associate

2 weeks ago


Remote, United Kingdom MAC Clinical Research Full time

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

If you have a bachelor's degree or equivalent in healthcare or scientific discipline, have significant on-site, independent monitoring experience, we want to hear from you.

You’ll be responsible for setting up, coordinating, and monitoring all activities at your allocated sites. You’ll need to be familiar with and able to work in compliance with the Study Protocols, Monitoring Plan and GCP (Good Clinical Practice) whilst ensuring work quality.

Effective communication and problem-solving skills are key for the smooth and timely completion and submission of accurate study data and query resolutions.

**ESSENTIAL**
- A Bachelor's degree or equivalent in a health care or other scientific discipline
- Significant on-site, independent monitoring experience. Preferably, a minimum of 3 years in a CRA role within the Pharmaceutical or CRO Industries.
- 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

**RESPONSIBILITIES**
- Performing site selection, initiation, monitoring, and close-out visits,
- Maintaining all documentation relating to study set-up and monitoring activities e.g., monitoring plans, visit reports, study status trackers
- Communicating regularly with assigned study sites and the project team
- Provide protocol and related study training to allocated sites
- Assess the quality of site practices, procedures and study data and escalating any quality issues as appropriate

**Management**
- You will assist in training and mentoring less experienced CRA’s and/or manage CRA’s 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

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

**Benefits**:

- Company pension
- Private medical insurance
- Work from home

Schedule:

- 8 hour shift
- Monday to Friday

**Experience**:

- Clinical Research Associate within a CRO: 3 years (required)
- On-site, independent clinical research monitoring: 3 years (required)

Work authorisation:

- United Kingdom (required)

Work Location: Remote

Reference ID: HR115



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