Sr. CRA 2, Oncology, FSP - Midwest
Fortrea•Durham, NC
•Remote
About The Position
Our FSP team is currently seeking an Oncology Sr. CRA 2 with 5+ years of monitoring residing in the Midwest (IL,IN,IA,KS,MI,MN,MO,ND,SD,WI, OH) area. You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.
Requirements
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
- 5+ years of Clinical Monitoring experience
- Oncology experience, early phase preferred
- 40-50% overnight travel
- Comfortable working in an environment that is fast paced, changing priorities constantly, teamwork and people skills are essential, and technology based.
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
- 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 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
