Clinical Research Associate I - Monitoring Excellence Academy
Clinical Research Associate I
Monitoring Excellence Academy
California, Home-Based, Remote
Start date: November 29, 2021
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Conducts site monitoring of clinical research studies according to our Standard Operating Procedures, ICH Guidelines and GCP.
Provideclinical support for project according to Covance Standard Operating Procedures, ICH Guidelines and GCP.
Site management responsibility for clinical studies according to Labcorp Standard Operating Procedures, ICH Guidelines and GCP.
Essential Job Duties:
- 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, with or without guidance (as per the training status of the CRAI-MEA); liaise with vendors; and other duties, as assigned
- Responsible for aspects of registry management as prescribed in the project plans
- General On-Site Monitoring Responsibilities:
- Assist Senior CRAs and CRA-2 with on-site tasks as required and according to training goals (e.g. review of Case Report Forms and Study File Notebook, drug accountability)
- Initiate, monitor and close out clinical investigative sites, with or without direct supervision from Senior Clinical Research Associates, Clinical Team Leads, Project Managers or Project Directors, as assigned based on training status and adequate skillset acquisition. On-site Routine Monitoring Visits should be accompanied by an experienced co-monitor (as per training status and agreement from Line Management).
- 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
- Monitor data for missing or implausible data
- Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Labcorp travel policy
- Travel, including air travel, may be required as per essential job functions.
- Prepare accurate and timely trip reports
- Perform CRF review, query generation and resolution against established data review guidelines, with or without direct supervision, on Covance by Labcorp or client data management systems, as assigned by management
- Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management
- Provide coverage for clinical contact telephone lines, as required
- Update, track and maintain study-specific trial management tools/systems
- Generate and track drug shipments and supplies, as needed
- Track and follow-up on serious adverse events as assigned
- Implement study-specific communication plan as assigned
- Attend investigators' meetings, project team meetings and teleconferences, as needed
- Perform other duties as assigned by management
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
- A minimum of 2 years of experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, etc.)
- COVID-19 vaccination required
- Basic understanding of ICH Guidelines and GCP including a basic understanding of regulatory requirements
- Basic understanding of the clinical trial process
- Valid Driver's License
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