Lead Clinical Research Associate (LCRA)

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 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 50% 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.

This role includes working from home and therefore we require you to have a set up at home that allows you to work comfortably. This includes an appropriate desk and chair (excl. IT equipment which we will provide), please confirm you are able to do this before proceeding with your application. 

•  A bachelor’s degree or equivalent in a health care or other scientific discipline
• A minimum of 5 years’ experience in a CRA role within CRO or Pharmaceutical Industries
• Significant experience of independent onsite monitoring from feasibility until close out (phases I – IV studies
• 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
• Advanced Knowledge of the regulatory framework that surrounds drug development and the clinical trial process
• ·Advanced knowledge of clinical trial process; including the interaction between operational and clinical teams, and sites
• Full and valid UK driving licence with business insurance cover

KEY RESPONSIBILITIES:

• Perform the Project Lead CRA role independently and at an advanced level of quality:
• Lead and oversee all clinical monitoring activities for assigned studies ensuring GCP and protocol compliance and delivery across sites
• Develop and coordinate the setup and delivery of clinical trial materials, systems and tools for study and site management
• Provide vendor management and support where required
• Lead, input into and support site selection and initiation, ensuring study CRAs are correctly and adequately trained on the therapeutic area and study, and are prepared to train site staff
• Lead, input into and support Investigator meeting set-up and conduct
• Prepare, implement, and maintain updates to study documentation including Monitoring Plan, Source Data Verification (SDV) Plan, Informed Consents, Clinical Trials Monitoring Risk Assessment
• Manage study progress by tracking regulatory submissions, site initiation, subject recruitment, Case Report Form (CRF) completion, and data query resolution
• Complete site visit report review within agreed timelines, reporting non-compliance and issue escalation where appropriate, addressing any study training needs identified
• Identify and document quality issues across study sites, study CRAs and study data, implement and oversee solutions and follow-up to satisfactory conclusions
• May conduct evaluation visits for study CRAs, providing timely and constructive feedback ensuring GCP compliance and ongoing CRA development. Escalate non-compliance to the Clinical Monitoring Manager and above
• Ensure the timely production of high-quality monitoring visit reports
• Identify, report, and manage potential study risks based on metric review of CTMS or other supporting systems and tools, escalating where appropriate and follow up to conclusion
•  Review and have oversight of Trial Master File (TMF) filing for Clinical Monitoring documents on assigned studies, ensuring the TMF is always audit ready
• Ensure CRAs review and have oversight of Investigator Site File (ISF) filing during monitoring visits and that regular reconciliation of essential documents against the TMF is documented in visit reports
• Provide project key performance indicators based on metric review of CTMS or other supporting systems and tools
• Liaise with Data Management to resolve data queries, recognise, and manage trends to support quality and compliance
• Ensure safety reporting is performed to study requirements, in collaboration with the CRA and pharmacovigilance team
• As needed, initiate investigator payments
• As needed, act as back up for monitoring activities, tasks and onsite visits if required.
• As needed, develop patient recruitment and retention strategies/plans

DEPARTMENT

• Input into the setting and delivery of department objectives aligned with company’s strategy.
• Support the oversight and management of Clinical Monitoring resources against project pipeline, input into the identification and implementation of resource strategies to ensure sufficient and qualified staff capacity to meet new business targets.
• Support the preparation, management, and response to QA audits (internal & external).
• Mentor CRAs in their progression towards their development objectives.

PROCESS

• Define and implement project specific strategies to allow the production of high-quality data.
•  Identify and resolve data issues.
• Provide oversight of CRA team members to ensure quality outputs and deliverables on assigned studies.
• Lead and contribute to ongoing department quality process and system improvements.
• Provide expert Clinical Monitoring inputs across MAC, their clients, and vendors.
• Proactively escalate to Management as appropriate in a timely manner.

• Private health Insurance
• 25 days annual leave plus bank holidays (increasing in increments to 30 days after 6 years long service)
• Free onsite parking
• 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 with an organisation that sees you as an investment and is keen for you to achieve your career aspirations.

Please email [email protected] 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.