Clinical Research Associate II, Phase I

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; liaise with vendors; and other duties, as assigned -
• Responsible for all aspects of site management as prescribed in the project plans
• General On-Site Monitoring
• 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 Monitor data for missing or implausible data
• Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested
• Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEs
• Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management
• Assist with training of new employees, eg. co-monitoring
• Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned
• Perform other duties as assigned by management

Preferred

• Ideal candidates would have phase I experience
• Ideal candidates would ... reside within the U.S

Benefits

• Remote work arrangement
• Global clinical research organization providing clinical development solutions.
• Durham, North Carolina, USA
• https://www.fortrea.com
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Qualifications

• 1+ years of on-site monitoring experience
• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
• 1+ years of Clinical Monitoring experience
• Phase I experience
• Teamwork and people skills are essential for the study to run smoothly
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf
• Ideal candidates would have phase I experience
• Ideal candidates would ... reside within the U.S
• 1+ years of on-site monitoring experience.

Required skills

• Clinical Monitoring, Phase I Clinical Research, Serious Adverse Event Reporting, Clinical Data Review

Preferred skills

• Ideal candidates would have phase I experience, Ideal candidates would ... reside within the U.S

Experience

• 1+ years