Clinical Research Associate II

Responsible for project activities associated with monitoring functions of phase I through phase IV clinical research studies and Real World Evidence (RWE) studies, while continuing to develop knowledge of drug development process, International Council for Harmonisation (ICH) / Good Clinical Practice (GCP), and relevant regulations.

Performs management of study site activities in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs).

What you'll do:


* Serve as the main CTI contact for assigned study sites


* Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in the Monitoring Plan while adhering to all applicable regulatory requirements, SOPs, and ICH GCP


* Assist with study start-up activities, including feasibility, pre-study activities, and site selection


* Collect, review, and track essential/regulatory documents


* Participate in and complete all general and study-specific training as required


* Participate in investigator, client, and project team meetings


* Create and implement subject enrollment strategies for assigned study sites


* Ensure proper storage, dispensation, and accountability of all Investigational Product (IP) and trial-related materials


* Perform site management activities and provide ongoing updates of site status to the Clinical Project Manager


* Conduct remote monitoring and complete the related activities in accordance with study study-specific Monitoring Plan



* Utilize systems and reports to track subject status, subject case report form (CRF) retrieval/source document review (SDV), regulatory documents, and IP


* Assist with project-specific activities as a member of the Project Team


* May support in the development of CRFs and other study-related documents (subject worksheets, Monitoring Plan, etc.)


* May support in the translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis, and other study-applicable documents as per required procedures


* Where applicable, provide support to the Regulatory Affairs Study Start-up Team in the preparation or
revision of documentation for submission to Ethics Committee(s), Institutions' Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow up on the evaluation process until approval is available.

Provide regular updates to the Sponsor/ Client


* Assist in preparing and coordinating Investigator and client meetings, and attend meetings as necessary


* Liaise with Clinical Data Management for data cleaning activities


* Identify site issues and implement corrective actions or escalate as appropriate


* Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans
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