Clinical Research Associate at ClinTec International

Job description

• 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