Medical Coding, Clinical jobs

• 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
• 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 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 RAY travel police
• Perform CRF review, query generation and resolution against established data review guidelines, with or without direct supervision, client data management systems, as assigned by management
• Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management
• Attend investigators’ meetings, project team meetings and teleconferences, as needed.

Education:

• Pharmacist / Medicine / Dentist.

Related Experience:

• Previous experience in clinical research field is preferablle

Work Location: In person