Senior Clinical Research Associate - CRO - US

Posted 19 June 2022
Salary Competitive
LocationUnited States of America
Job type Full Time
Discipline CRO & Clinical Operations
Contact NameIvanoel Alexandre

Job description

Mantell Associates are currently partnered with a top 5 Leading CRO in their search for an Senior Clinical Research Associate based in the United States.

​Are you looking for a Senior 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!

The company we are currently partnered with are a leading Top 5 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 3 Pharma and would allow for remote flexibility.

Senior 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.

Senior 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.

​Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact Ivanoel Alexandre on +44 (0)2038547700 or Ivanoel.alexandre@mantellassociates.com