Clinical Research Associate I

at  MAC Clinical Research

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 fill 3 permanent positions at the Clinical Research Associate level 1 (CRAI). We are looking for experienced professionals to join our dedicated Clinical Monitoring team and make a positive impact in a growing and progressive CRO.
The focus of this role is to coordinate activities for setting up and monitoring studies at allocated sites to ensure quality and compliance with the study Protocol, Monitoring Plan, Good Clinical Practice, standard operating procedures and applicable regulatory requirements.
This is a hybrid role that requires travel to any one of the MAC sites (Glasgow, Greater Manchester, Lancashire, Merseyside, South Staffordshire, South Yorkshire, Teesside and West Yorkshire). You must be available to travel around 70% of the time, for this reason we’re inviting applications from applicants who have a full and valid UK driving licence with access to their own transport and insured for business travel.

KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED:

• A Bachelor’s degree or equivalent in a health care or other scientific discipline or experience in a CRA role
• Experience in Phase I-IV study trials within the pharmaceutical industry
• At least 3 months of experience in independent onsite monitoring
• 1 years experience in a CRA role within the CRO or Pharmaceutical 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 work in a collaborative team environment.
• Able to proactively identify risks and issues.
• 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.

• Perform the Project CRA role with oversight and support where needed:
• Facilitate effective communications as primary contact point for investigator sites, sponsor and MAC project team through written, oral and/or electronic contact reports.
• Verify the study Investigators and site personnel are conducting the study in compliance with protocol, ICH-GCP and applicable regulatory requirements.
• Conduct Pre-study or site selection (PSSV), site initiation (SIV), remote monitoring (R-IMV), risk-based monitoring (rb-IMV), close out visits (COV) according to the agreed scope of work.
• Document and record monitoring activities and observations in CTMS/agreed reporting system within required timelines. Escalate observed deficiencies and issues to the LCRA and project team expeditiously. Follow and record issues through to resolution.
• Develop high levels of familiarity and compliance with study specific Monitoring Plan, Project Plan and Risk Assessment, raising issues as needed.
• Monitor and report on clinical study progress, working with Data Management to ensure steady flow of data and data queries as per project timelines.
• Confirm reported data is correct, accurate, complete, and verifiable against source documentation as per the project Monitoring Plan. Raise data queries in the production of clean data and follow up to conclusion.
• IMP/Device management and accountability
• Identify and communicate potential project risks and issues
• Attend investigator meetings.
• Provide site training, acting as site process specialist, ensuring the study is conducted as per protocol, ICH GCP, applicable regulations and SOPs to guarantee participants rights, well-being and data reliability.
• Prepare for Interim and Database Lock.
• Review study documentation for compliance and to ensure identification and reporting of safety issues, when applicable, from research site staff to the LCRA, project team, sponsor and the IRB/IEC.
• Review accuracy and completeness of site records (i.e., essential documents relating to the clinical study which will enable quality and conduct to be evaluated as per ICH GCP and EudraLex, query resolution, and other data collection tools);
• Ensure the site is identifying issues and implementing corrective and preventive actions to ensure inspection readiness.