The Clinical Research Associate ll 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
University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing, medical or laboratory technology
Minimum of four (4) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits) at a Pharmaceutical, Biotech or CRO company. Diagnostic and/or Medical device experience preferred.
Oncology experience preferred
Thorough knowledge of ICH/GCP Guidelines, including a basic understanding of regulatory requirements in other countries
Advanced site monitoring skills
The ability to thrive with minimal supervision
The drive to resolve project-related problems and can prioritize workload for self and team
Efficient and effective work habits in a matrix environment, internally and externally.
A flexible attitude to adjust to changing needs
The ability and willingness to travel up to 70% of the time.
Excellent knowledge of MS Office as well as project management and clinical trials software.
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