- MAC - FULL TIME
LEAD CLINICAL RESEARCH ASSOCIATE
Closing date for applications: 2 June 2023
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 as a CRA, then we want to hear from you.
This role is remote with regular onsite visits to our various clinics across the North West and North East of England.
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.
Able to proactively identify risks and issues and be able to devise mitigation and contingency plans and solve problems as they arise. Encourage other team members to apply the same approach to seek solutions.
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
Line management and training of allocated CRA’s, and other departmental roles, working on international projects.
Initiate changes in working practices
Provide practical solutions for problems
Motivate, encourage, and train other members of the CRA team
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)
Your birthday off work
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.
Salary: Competitive + Negotiable £ Apply Now