FSP - Sr CRA & CRA 2 - Oncology - Central & Midwest US

Role Summary

Experienced Oncology CRAs residing in the Central & Midwest US to join our FSP team. Various openings include regional travel as well as nationwide travel options.

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 monitoring 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 reports, 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

Qualifications

• Required: University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
• Required: 3+ years of onsite Clinical Monitoring experience
• Required: Oncology experience
• Required: Open to major hub locations in Central & Midwest

Skills

• Communication and collaboration with cross-functional teams
• Clinical trial monitoring and data integrity focus
• Regulatory and ethics compliance knowledge

Education

• University degree or equivalent in a related field (or nursing licensure)

Additional Requirements

• Travel: Frequent travel to clients/site locations with occasional travel both domestic and international
• Work Environment: Office-based with exposure to electrical equipment
• Physical Requirements: Ability to sit for extended periods and operate a vehicle safely; repetitive hand movements; occasional crouching, stooping, bending and twisting; ability to lift 15-20 lbs; use of computer software