CTA II

​09 Dec 2021

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​Bionical Emas - the Company

​Bionical Emas is the only CRO to combine Clinical Development, Early Access Programs and Clinical Trial Supply, delivering a unique, seamless approach to bring life-changing medicines to patients around the world.

​With clients, staff and offices around the globe, we offer a varied and international experience.

Our clients range from smaller biotech’s to large global pharmaceutical companies, all with different needs and expectations.  As a business, we have invested heavily in ensuring we have the systems, processes, and people, to deliver for the very varied requirements of our clients. The culture of Bionical Emas is friendly, flexible and supportive, where all staff are encouraged to grow, develop and exceed their expectations.

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Main Responsibilities

• CTA II with solid experience on East Coast USA

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​Key things we are looking for

• Experienced CTA within Clinical Research, CRO preferred

• Experience in Feasibility and Study Start Up activities to include ethics/regulatory submissions

• Study site communication via email and phone

• Coordinate departmental communications and provide efficient in-house back-up in absence of team members

• Set-up and manage the content of project Trial Master Files (eTMF), and ensure accuracy and completeness; file or upload and QC documents

• Manage the set-up and distribution of Investigator Site File binders, including Pharmacy binders (as applicable)

• Set-up and manage the content of project specific SharePoint sites; upload documents; grant user access

• Set-up and manage project specific mailboxes as applicable; review and retrieve documents for filing in the TMF and/or SharePoint

• Develop, set-up and maintain department and project-specific (e.g. site feasibility, protocol and IB distribution, subject status, etc) tracking systems, including CTMS if applicable

• Manage and track study material distribution and receipt as needed

• Participate in Project Team meetings as required; prepare and circulate meeting agendas and minutes as required

• Manage administrative aspects of regulatory and ethics submissions, subsequent communications and updates as applicable

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​At Bionical Emas, we are committed to supporting our clients and our staff, so that they can bring life-changing medicines to patients around the world. Join Bionical Emas on our mission to make a difference. 

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