Clinical Research Associate II

1 week ago

United Kingdom MAC Clinical Research Full time

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 have an open permanent position for a CRA II and are looking for an experienced professional to make a positive impact in a growing and progressive CRO.

The role is open to applicants who have around 7 years of clinical research experience with a minimum of 3 years as a CRA and a minimum of 2 years with independent site monitoring experience within a CRO.

This is a remote working position with travel to clinical sites for independent, study monitoring as required.

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, on-site 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.

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 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.

PLANNING AND ORGANISATION

  • Prioritise and monitor own workload to ensure the correct studies are being focused on at the correct time, escalating 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.
  • Develop ideas for improving systems within the company.

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 maccareers@macplc.com 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.

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