Mantell Associates are currently partnered with a top 10 Leading CRO in their search for an Initiation Clinical Research Associate based in the United Kingdom.

​Are you looking for a Study Start up phase CRA position to progress as your next opportunity?

Would you like to work for one of the leading CRO's on the planet?

​Are you looking to move away from your typical CRA position?

Then this is the job for you!

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The company we are currently partnered with are a leading Top 10 CRO who are going from strength to strength and spearheading their growth in Oncology and COVID-19 trials, the position would be sponsor dedicated to top 5 Pharma and would allow for remote flexibility.

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Initiation Clinical Research Associate Responsibilities:

• Form bonds with investigators and site personnel.

• Conduct, drive, and manage country-specific feasibility and/or site prequalification and qualification efforts, such as preparing, negotiating, and facilitating the execution of Confidentiality Agreements (CDAs), Clinical Site Agreements (CSAs), and any changes.

• Conduct Qualification Visits from afar (QVs).

• Develop a plan for configuring, distributing, and collecting high-quality country-specific and/or site-specific papers, as well as any updated or changed regulatory material, as well as reviewing and approving them.

• Customize, evaluate, and negotiate country/site specific Informed Consent Forms (ICF), translations (within country/regulatory/client requirements), and any revisions as needed.

• Prepare and submit IRB/IEC and MoH/RA (if applicable) applications, resolving disagreements as needed, and deciding necessary follow-up until final approval is received.

• As per project plans/sponsor/company policies, submit all essential paperwork to the trial master file.

• IRB/IEC and MoH / RA submission/approval, Site activation, Patient recruiting & retention: forecast, establish, monitor, and adjust plans and strategies.

• Timely updates and maintenance of adequate Clinical Trial Management Systems (CTMS) are required.

• Provide assigned sites with access to necessary research systems and ensure that they are up to date on all project-specific training needs prior to the commencement of the study.

• As needed, actively engage in investigatory and other external or internal meetings, audits, and regulatory inspections.

• On a regular basis, evaluate the site recruiting plan in partnership with the site employees and give a strategy for improvement.

• Conduct on-site visits, including Qualification and Initiation visits; use judgement and knowledge to handle site issues, questions, and concerns independently.

• As requested/needed, do remote visits/contacts.

• Assess and manage the supply of test articles and studies, including their availability, accountability, and destruction/return status.

• Produce visit/contact reports, employing judgement to identify site concerns and problem-solving techniques to guide resolution.

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Initiation Clinical Research Associate Requirements:

• A bachelor's degree in science is necessary. It is preferable to work in a medical or pharmacy setting.

• Strong computer abilities, including knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office applications such as Excel and Word, but not limited to.

• Good problem-solving abilities.

• Capable of taking initiative and working alone, as well as seeking help when needed.

• Improve your presenting abilities.

• Work is done with the client in mind.

• Professional ability to communicate within a client organisation.

• In terms of job tasks and new learning, I have a flexible mindset.

• Due to the unexpected nature of the difficulties that develop, the ability to prioritise many activities and meet project deadlines; using excellent analytical abilities to make independent decisions.

• Willingness to work in a matrix setting and a belief in the advantages of collaboration.

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Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact Lewis Joshi on +44 (0)2038547700 or lewis.joshi@mantellassociates.com