Join to apply for the Senior Clinical Research Associate role at MAC Clinical Research
This is a hybrid role that requires travel to 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 and have a full and valid UK driving licence with access to your own transport, insured for business travel and able to commute daily to any MAC clinic.
KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED
* A Bachelor's degree or equivalent in a health care or other scientific discipline
* A minimum of 3 years in a CRA role within the Pharmaceutical or CRO industries
* Significant on-site, independent monitoring experience
* Good knowledge of drug development process, regulatory framework and the overall clinical trial process
* 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 devise mitigation and contingency plans
KEY RESPONSIBILITIES
Performs the Project CRA role independently and at an advanced level of quality.
* Facilitate effective communications as primary contact point for investigator sites, sponsor, and MAC project team through written, oral and/or electronic contact reports
* Verify site conduct complies with protocol, ICH-GCP and applicable regulatory requirements
* Conduct Pre-study/site selection (PSSV), site initiation (SIV), remote monitoring (R-IMV), risk-based monitoring (RB-IMV), and close-out visits (COV) as per scope of work
* Document and record monitoring activities in CTMS within required timelines; escalate deficiencies to LCRA and project team; follow through to resolution
* Develop familiarity with Monitoring Plan, Project Plan and Risk Assessment; raise issues as needed
* Monitor and report study progress; collaborate with Data Management to ensure data flow and queries align with project timelines
* Confirm data accuracy against source documentation; raise data queries and ensure clean data
* IMP/Device management and accountability
* Identify and communicate potential risks and issues
* Attend investigator meetings
* Provide site training and ensure study conduct per protocol, ICH GCP, regulations and SOPs, safeguarding participant rights and data quality
* Prepare for interim or database lock
* Review study documentation for compliance and safety reporting to LCRA, project team, sponsor and IRB/IEC
* Review site records for quality and conduct; support CAPAs and inspection readiness
* Support the Lead CRA in oversight, planning and management of the study
PLANNING AND ORGANISATION
* Prioritise and manage workload to focus on correct studies at the right time; escalate as needed
* Identify quality problems and recommend solutions
* Assist in harmonisation of processes across MAC sites
* Collaborate with colleagues to ensure corrections and updates are completed promptly
DEPARTMENT AND PROCESS
* Provide oversight of CRA team members to confirm quality of work
* Conduct study-specific evaluation visits if required and delegated following training
* Contribute to ongoing department quality processes and system improvements
* Support ongoing training, mentoring and development of Clinical Monitoring team members
* Provide expert Clinical Monitoring inputs across MAC, clients, and sites
* Escalate to Management as appropriate in a timely manner
BENEFITS
* Health Insurance
* Free onsite parking
* 25 days annual leave plus bank holidays (increasing to 30 days after 6 years)
* Your birthday off work
MAC Clinical Research invites applications from highly motivated candidates who are committed to achieving their full potential. We are an organization that values its people and supports career development.
This role is home-based and requires a suitable home setup (desk and chair). IT equipment is provided by MAC.
Please email maccareers@macplc.com should you require any special arrangements or reasonable adjustments during the selection process.
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