The Clinical Research Associate (CRA) is responsible for managing and monitoring the conduct of clinical projects according to ICH-GCP, Standard Operating Procedures (SOP), and applicable Project Management Plan (PMP) and local regulatory requirements.
Requirements
- Contribute comments/input in the development of Protocol, Informed Consent Form (ICF), Case Report Forms (CRF) and other project related documents.
- Perform site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
- Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings.
- Provide guidance at the site and project level towards audit readiness standards and support preparation for audit and required follow-up actions.
- May provide training or mentorship to more junior level CRAs.
- May perform training and sign-off visits for junior CRA staff, as assigned.
- May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager.
