Sr Clinical Research Associate (CRA)

Job description

Let’s talk about some of the key responsibilities of the role: - As an investigator site facing role, the Sr. CRA will act as a customer advocate through a study life cycle. - Understand and support study goals in alignment with corporate goals. - Organize and maintain clinical study documentation (e.g., Trial Master Study Files) including preparation for internal/external audits, final reconciliation and archival. - Where appropriate, responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits and appropriate documentation (confirmation, follow-up letters, communication logs, as required). - When monitoring has been delegated to a CRO, provides Sponsor oversight of monitoring activities. - Assists in the development of study specific monitoring procedures and guidelines. - Involved in the development or review of protocols, Case Report Forms (CRFs), informed consent forms and any other study-related documents as assigned. - Assists in managing the identification, selection and feasibility processes of study sites. - Ensures the study sites have received the...