Join to apply for the CLINICAL RESEARCH ASSOCIATE II role at MAC Clinical Research.
This is a remote 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 be located central to the MAC sites.
KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED
* A Bachelor's degree or equivalent in a health care or other scientific discipline
* A minimum of 2 years’ independent monitoring experience within clinical research either in a CRO or Sponsor company
* Experience working across phase I-IV trials
* Excellent computer skills including use of Microsoft Office
* Excellent oral and written communicative skills, with English fluency
* 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, surrounding regulatory framework and the overall clinical trial process
* Good working knowledge of the relationship between the CRO industry and pharmaceutical companies
KEY RESPONSIBILITIES
* Performs the Project CRA role independently with appropriate escalations as needed
* 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 Lead CRA and project team expeditiously; follow and record issues through to resolution
* Develop familiarity with study Monitoring Plan, Project Plan and Risk Assessment, raising issues as needed
* Monitor and report on clinical study progress, collaborating with Data Management to ensure data flow and data queries align with project timelines
* Confirm reported data is correct, accurate, complete, and verifiable against source documentation; raise data queries to produce 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 database lock
* Review study documentation for compliance and ensure reporting of safety issues to the LCRA, project team, sponsor, and the IRB/IEC as applicable
* Review accuracy and completeness of site records to enable quality and conduct evaluation as per ICH GCP and EudraLex; manage query resolution and data collection tools
* Ensure the site identifies issues and implements corrective and preventive actions to ensure inspection readiness
PLANNING AND ORGANISATION
* Prioritise and monitor own workload to ensure studies are addressed at the correct times
* Identify quality problems and recommend solutions
* Assist in harmonisation of processes across all MAC sites
* Work with colleagues to ensure corrections and updates are completed appropriately and in a timely manner
* Develop ideas for improving systems within the company
BENEFITS
* Competitive salary in keeping with pharmaceutical industry standards that will reflect experience
* Health Insurance
* Eye Care Vouchers
* Cycle to work scheme
* Free onsite parking
* 25 days annual leave (increasing 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.
This role is home based and requires a home setup that allows you to work comfortably, including an appropriate desk and chair (IT equipment provided by us).
Please email maccareers@macplc.com should you require any special arrangements or reasonable adjustments to be made throughout this selection process.
Employment type: Full-time; Seniority level: Not Applicable; Job function: Research; Industries: Research Services, Pharmaceutical Manufacturing, and Hospitals and Health Care
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