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A leading company in the brain health technologies is looking for an experienced and passionate Senior Study Start-Up & CRA. You will join a dynamic and fast-paced environment and work with cross-functional teams to design, build and roll-out products that deliver the companys vision and strategy.
You will be involved in most Clinical activities: Conduct research and maintain proficiency of EU local requirements for documentation of IRB/EC and Regulatory Authority submission approvals, and subsequent follow-up documentation.
Liaise with study sites regarding essential document collection and assisting with IRB/EC submissions.
Compile and submit CTAs
Customize country/site specific Patient Information Sheet and Informed Consent Forms and reviewing study documents.
Review translations of regulatory documents.
Provide regular local status updates to Director of Regulatory and Clinical Affairs; update appropriate study-tracking tools with local essential document and ethics committee status and maintain project tracking systems for assigned projects.
Ensure all relevant documents are submitted to the Trial Master File (TMF)
Support the development of start-up plans and essential document checklists.
Perform on site monitoring when required.
Assist in protocol writing.

A leading company in the brain health technologies is looking for an experienced and passionate CRA. You will join a dynamic and fast-paced environment and work with cross-functional teams to design, build and roll-out products that deliver the companys vision and strategy.
The primary role will be to provide overall support to the clinical affairs Manager and serve as a point of contact to the company's internal clinical queries in addition to performing monitoring to ongoing studies. You will administer, monitor, maintain and co-ordinate the logistical aspects of clinical trials in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs).
Primary Roles & Responsibilities:
The CRA will be involved in most Clinical activities:
Ensure that any clinical trial databases/ tracking tools are set up and maintained throughout the trial.
Assist with the Ethics / Regulatory Submissions; keep a track of submissions & approvals for the study.
The set up and maintenance of the Trial Master Files (TMF) and additional general study filing.
Managing and maintaining study documents & trial supplies.
Preparing essential clinical trial documentation, distributing, tracking and filing of documents on return.
Setting up of finance systems accurately, processing invoices & tracking payments for the trial for investigator payments.
Updating and writing Clinical SOPs.
developing and writing trial protocols.
designing data collection forms, (CRFs);
liaising with doctors/consultants or investigators on conducting the trial;
setting up the trial sites, which includes ensuring each center has the trial materials and supplies and training the site staff to trial-specific standards;
monitoring the trial throughout its duration, which involves visiting the trial sites on a regular basis;
verifying that data entered on to the CRFs is consistent with patient clinical notes (SDV);
writing visit reports and filing and collating trial documentation and reports;
Close out of trial sites on completion of the trial;
archiving study documentation and correspondence;
preparing final reports and occasionally manuscripts for publication.