Job Description

Position Summary:

The Sr. Clinical Research Associate (CRA) is responsible for management and monitoring activities that will lead to successful execution of clinical studies.  They will proactively identify and resolve clinical project issues and participate in process improvement initiatives as applicable.  The CRA engages with study investigators, vendors and internal/external stakeholders as a member of the Clinical Trial Operations team. 

Essential Duties and Responsibilities:

• 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.
• Involvement in the generation of project plans, especially those related to site management, monitoring and reporting.
• Involved in the development of protocols and Case Report Forms (CRFs) as assigned.
• Manage the identification, selection and feasibility processes.
• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
• Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
• Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review and monitor for missing or implausible data.
• Prepare accurate and timely trip reports. 
• Organize and make presentations at Investigator Meetings.
• Interact with internal groups to evaluate needs, resources and timelines.
• Act as contact for clinical trial supplies and other suppliers (vendors) as assigned