SENIOR CLINICAL RESEARCH ASSOCIATE
Closing date for applications: 31 July 2021
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 Senior Clinical Research Associate 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 full time and is field/home-based with business related travel as required.
The purpose of this role is to lead all activities required for contributing to set up and monitoring a study.
You must be available to travel at least 70% of the time (within the UK and internationally – including flying) and you should possess a full and valid UK driving licence.
Monitor or supervise the monitoring of studies at allocated sites to ensure quality and compliance with the study Protocol, Monitoring Plan and GCP.
Perform or ensure junior staff can adequately perform site selection, initiation, monitoring and close-out visits
Maintain all documentation relating to study set-up and monitoring activities e.g. monitoring plans, visit reports, study status trackers or supervise junior CRAs to do so.
Communicate regularly with assigned study sites and the project team.
Provide protocol and related study training to allocated sites or supervise junior CRAs to do so.
Manage study progress by tracking regulatory submissions, site initiation, subject recruitment, CRF completion, and data query resolution or supervise junior CRAs to do so.
Assess the quality of site practices, procedures and study data and escalating any quality issues as appropriate
Complete and submit accurate study status reports to the project team in a timely manner or supervise junior CRAs to do so.
Responsible for maintaining all study monitoring documentation or supervise junior CRAs to do so.
Manage the query resolution process effectively by liaising with the project team and the study site(s) or supervise junior CRAs to do so.
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 and experience across phases I – IV.
Experience supervising, training, and mentoring of less experienced CRAs.
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.
Able to proactively identify risks and issues and be able to devise mitigation and contingency plans and solve problems as they arise.
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 operation
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.
Competitive salary in keeping with pharmaceutical industry standards and will reflect experience
Free onsite parking at MAC office locations
25 days annual leave plus bank holidays (increasing in increments to 30 days after 6 years service)
Your birthday off work
Regular hours (including Christmas Day, Boxing Day and New Years Day off)
MAC Clinical Research invites applications from highly motivated candidates, with a desire to achieve their full potential. You will be working with an organisation that sees you as an investment and is keen for you to achieve your career aspirations.
Closing date: 31st July 2021
Please note that if we receive a high volume of applications this date may be brought forwards.
Salary: Competitive + Negotiable £ Apply Now