Clinical Research Associate
PositionUnder direct supervision, monitors and oversees clinical practices for one or more multisite clinical investigations conducted by the client, ensuring compliance with ICH-GCP or ISO 14155 and applicable regulatory requirements.
Maintains sound clinical practices to ensure validity of study.
Monitors the conduct and progress of the study to ensure compliance to protocol and clinical study schedule.
Participates in study initiation, monitoring and close-out activities.
Identifies and reports complaints, adverse events ((S)AE) and other safety issues.
To report on his/her activities and provide status updates in a timely manner to the project leader and/or manager.
To assist in the startup of investigational sites including investigator identification, investigator meetings and shipment of study supplies.
To assist in the review and development of project-related documentation, materials and procedures.
To ensure that tracking systems/databases and filling of study related documents remain updated.
To participate in and contribute to project meetings, departmental meetings, training activities and cross-functional activities as required.
To facilitate a timely and accurate communication flow between the investigational sites and vendors.
To develop and maintain an awareness of and be responsive to internal and external customer needs.
Reports to the CRM or Project Manager.
ProfileGood working knowledge of ICH-GCP and applicable regulatory requirements
Working knowledge in multiple therapeutic domains
Ability to supervise and train site study staff
Trilingual Dutch, English, French
Strong ethics & commitment
Prioritize goals and objectives
2 - 6 years of experience as Clinical Research Associate
MEDICONSULT is the member firm of the VANDYCKE group, specialized in Clinical Consultancy Services for the Healthcare Business (pharmaceutical industry, medical devices, biotechnology, hospitals, service providers, ...).
Iwona de Pourbaix