Clinical Research Associate – Prague, Czech Republic – Permanent Contract

ClinTec International is actively recruiting for a Clinical Research Associate to join our expanding global company in Czech Republic – this is a Permanent contract, Office based opportunity in Prague. By working for ClinTec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.

Role Description

The Clinical Research Associate will identify, select, initiate and close-out appropriate investigational sites for clinical studies. The successful candidate(s) will monitor these sites in order to ensure ensuring compliance to the study protocol, Standard Operating Procedures, applicable regulations, and the principles of ICH-GCP. The CRA will also be charged with ensuring the quality and integrity of data, compliance with relevant SOPs and regulatory requirements and study completion on time and within budget.

Responsibilities of the Clinical Research Associate:

· Monitor clinical trials to ensure absolute adherence to Good Clinical Practice in accordance with ICH-GCP standards, Declaration of Helsinki, Federal Regulatory Requirements and study procedures

· Site management to ensure proper adherence to protocol, source data verification and assess CRF entries

· Develop, review and edit clinical trial related documentation including but not limited to; Case Report Forms, Informed Consent Forms, study specific handbooks, guidelines and checklists

· Assist with study protocol design, development and / or review if required

· Complete and compile all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval where required

· Perform pre-study initiation, interim monitoring and close out visits as required

· Carry out drug formulation administration procedures and documentation records

· Ensure adequacy of drug shipment and drug accountability

· Liaise with the Medical Monitor, Principal Investigator, clinical operations staff and sponsor representatives as required

· Organise / attend investigator meetings as required

· Provide support to the Project Manager / Country Manager with ad-hoc tasks as required