Senior Clinical Research Associate

Posted 19 June 2022
LocationUnited States of America
Job type Full Time
DisciplineCRO & 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 20 455 11036 or Ivanoel.alexandre@mantellassociates.com