Senior CRA

Duties and responsibilities (according to relevant guidelines, laws and procedural documents):

• Gain a thorough knowledge and understanding of the protocol and all relevant sections of associated documents before performing trial related activities.
• Conduct investigational site evaluation, initiation, interim monitoring and close out visits.
• Ensure the required and correctly completed essential documents are in place prior to trial start-up and on an ongoing basis throughout the trial.
• Ensure administrative set-up of sites, laboratories and/or storage facilities, in accordance with trial-specific requirements.
• Organise and participate in investigator meetings as necessary.
• Verify that trial sites are adequately staffed and that relevant trial site team members understand their roles and responsibilities and, in collaboration with the site principal investigator (PI), that the site staff are sufficiently qualified, trained and experienced to complete tasks assigned to them.
• Initiate clinical trial sites according to relevant procedures to ensure compliance with the protocol, regulatory and GCP obligations.
• Verify data versus source documentation and validate case report form (CRF) entries. Review data for completeness, medical sensibility, plausibility and accuracy. Generate and resolve queries as required.
• Control investigational product accountability through physical inventory and records review. Verify trial supplies ordering, dispatch, transit processes, storage, dispensing, return and destruction where applicable.
• Document all monitoring activities in the monitoring report, letters and supporting documentation and submit for review within the prescribed timelines.
• Ensure that serious issues and other matters of concern are immediately brought to the attention of the PM, with adequately documented support and follow-up until resolution, in accordance with the relevant SOP and other stipulated processes.
• Provide trial status tracking and progress reports as required by the PM.
• Assist with in-house review of CRFs, query writing and query resolution, CRF tracking, and liaise with data management division for specified trial.
• Conduct and ensure adequate trial close-out and retrieval of trial materials.
• As necessary, assist with the preparation and submission of applications to regulatory, ethics and other relevant authorities.
• Maintain a working knowledge of GCP, Triclinium Procedural Documents and applicable sponsor SOPs.
• Develop management skills and take the necessary initiative to support, advise and guide investigative site staff towards meeting trial objectives.
• Facilitate effective documented communication between investigational sites and the Triclinium project team.
• Facilitate and respond to company and sponsor audits and regulatory inspections.
• Contribute to the project team by mentoring new members, assisting in the preparation of project tools and sharing ideas and suggestions with team members.
• Archive relevant documents as per procedures.