Bachelor degree or above, in pharmacological or medical or scientific related field
Must be able to travel if required.
Must be able to lift 50 lbs
Job Description:
SUMMARY
The primary function of a Trainee CRA is to develop basic monitoring skills through the completion of monitoring training and successfully
passing a monitoring assessment and evaluation. The Trainee CRA will also support the clinical monitoring team by providing in−house
and project support.
RESPONSIBILITES
Complete required foundation monitoring training within required timeline, and complete the evaluation and assessment.
Provide in−house project support to CRAs
uploading of documents to Global Drive, translation of documents, visit scheduling and site management, assisting in the study start
up phase (recruitment of investigators, collect CDA’s and SID’s) assembling of document packages for monitoring visits, adaptation of
documents, essential documents collection, preparation of the transmittal form for shipment of documents to the PMF, support of ISF
preparation, review of retrieved study documents, follow−up with investigators when necessary.
Provide on−site project support to CRAs, including SDV, IP accountability, ISF review and essential documents collection, etc
Support on Ethics Committee (EC)/Competent Authority (CA) Submissions: Find out the relevant information regarding submission
dates, meeting dates and collating relevant documents. Prepare the required package for submission and ensuring that submission dates
are met. Complete non−scientific or technical parts of the submission forms, and type covering letters to investigators or ECs/CAs.
Follow up and ensure requests from ECs and CAs are answered within time limits, liaising with CRAs regarding changes. Re−check all
letters of approval that they contain the correct protocol title and date, amendments where required and obtain a list of the Ethical
Committee members.
Support the planning of investigator meetings, finding suitable dates, organizing appropriate hotels and travel arrangements,
equipment, meals and any other requirements (if applicable)
Support in any study specific duties when required, for example re−numbering of blank CRFs, liaison between Company offices to
communicate updated status or updated EC/CA submissions/approvals and general support the monitoring team in administrative duties.
Attend the project CRA meeting and training meetings.
Feasibility assessment support – Identification of appropriate potential sites based on internal list (IRDB or local recommendations, or
internet research), first contact and follow−up of sites identified, shipment and collection of feasibility documents according to feasibility
specific instructions (CDA, Synopsis, Questionnaire), update of feasibility specific tracker and shipment of interim and final update to
feasibility coordination as required.
Support of the clinical monitoring team in routine duties such as organizing effective routes of communication, pass on and follow−up
messages, photocopying, organize appointments.
Support to update regularly the Clin Mon databases (i.e. Metrics, Resource Tool, ASV tracker).
Theorem Clinical Research - 30+ days ago
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