Senior Clinical Research Associate in UK

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 an opening for Senior CRA and are looking for experienced professional to make a positive impact in a growing and progressive CRO.

This is a remote role with visits to sites as required.

Focus of the role

• 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
• A minimum of 4 years in a CRA role within the Pharmaceutical or CRO Industries with on-site, independent monitoring experience.
• Good knowledge of drug development process, surrounding regulatory framework and the overall clinical trial process.
• 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.

KEY RESPONSIBILITIES:

Performs the Project CRA role independently and at an advanced level of quality:

• Facilitates 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 or data base 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.
• Support the Lead CRA in the oversight, planning and management of the study.

PLANNING AND ORGANISATION

• Prioritise and monitor own workload to ensure the correct studies are being focused on at the correct time, escalation as appropriate.
• Identify quality problems and recommend solutions.
• Assist in harmonization of processes across all MAC sites.
• Work with colleagues to ensure corrections and updates are completed appropriately and in a timely manner.

DEPARTMENT AND PROCESS

• Provide oversight of CRA team members to confirm quality of work.
• Conduct study specific evaluation visits if required and delegated on the provision that evaluation visit training has been completed prior to delegated task.
• Contribute to ongoing department quality process and system improvements.
• Support ongoing training, mentoring and development of Clinical Monitoring team members.
• Provide expert Clinical Monitoring inputs across MAC, their clients, and sites.
• Proactively escalate to Management as appropriate in a timely manner

BENEFITS:

• Competitive salary in keeping with pharmaceutical industry standards that 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 email should you require any special arrangements or reasonable adjustments to be made throughout this selection process.

This will enable us to accommodate your request as necessary.