- MAC - FULL TIME
SENIOR CLINICAL RESEARCH ASSOCIATE
Closing date for applications: 31 May 2023
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 dedicated Clinical Monitoring team.
This is a remote role with travel to sites as and when required.
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 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).
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. (a minimum of 3 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
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
Manage study progress by tracking regulatory submissions, site initiation, subject recruitment, CRF completion, and data query resolution.
Assess the quality of site practices, procedures and study data and escalating any quality issues as appropriate
Benefits
Competitive salary in keeping with pharmaceutical industry standards and 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
MAC Clinical Research invites applications from highly motivated candidates, with a desire to fulfil 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.
Please note that if we receive a high volume of applications this role may be closed.
Salary: Competitive + Negotiable £ Apply Now
