• MAC

CLINICAL RESEARCH ASSOCIATE II

Closing date for applications: 30 June 2021

MAC Clinical Research manages clinical trials for the pharmaceutical industry and we are seeking to appoint a Clinical Research Associate II to join our team and make a positive impact in a world-leading Clinical Research Organisation.


We are happy to be flexible with regards to location, as this role is field based with travel to allocated study sites as required.


The focus of this role is to coordinate all activities required for setting up and monitoring a study.


KEY RESPONSIBILITIES:

  • 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.

  • Maintain all study monitoring documentation.

  • Manage the query resolution process effectively by liaising with the project team and the study site(s).

  • Verify that the research site investigator(s) and study personnel are conducting the study according to the clinical protocol, “Good Clinical Practices”, and regulatory requirements to ensure protection and ethical treatment of human subjects.

  • Ensure identification and reporting of safety issues, when applicable, from research site staff to the sponsor and the IRB/IEC.

  • Perform monitoring activities per the monitoring plan (e.g., verification of source documents and eCRF/CRFs, site communications, follow up on data anomalies, etc).

  • Review accuracy and completeness of site records (i.e., essential documents, query resolution, and other data collection tools);

  • Ensure that accountability of Investigational Product and related supplies are performed, when appropriate.

  • Ensure complete reporting and proper documentation of monitoring activities.

  • Conduct routine monitoring visits (on site or remotely) independently from the investigative site study staff.

  • Ensure the site is identifying issues and implementing corrective and preventive actions to ensure inspection readiness.


KEY REQUIREMENTS:

  • A Bachelor's degree or equivalent in a health care or other scientific discipline.

  • Minimum of 2 Years’ experience of independent monitoring within clinical research in either a CRO or Sponsor company.

  • Experience across phases I – IV.

  • 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 work in a collaborative team environment.

  • Able to proactively identify risks and issues .

  • Knowledge of drug development process including the relationship between the CRO industry and Pharmaceutical companies.

  • Knowledge of the regulatory framework that surrounds drug development and the clinicaltrial process.


BENEFITS:

  • Competitive salary in keeping with pharmaceutical industry standards and will reflect experience

  • Free onsite parking

  • 25 days annual leave plus bank holidays (increasing in increments to 30 days after 6 years service)

  • Your birthday off work

  • Regular hours (including Christmas Day, Boxing Day and New Years Day off)


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 note that if we receive a high volume of applications this date may be brought forwards.



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