Sr CRA - Oncology - FSP - North Central & West Coast

Role Summary

Experienced Oncology Clinical Research Associate (CRA) for North Central (IL, MN, MO, IA, KA) or West Coast (CA, AZ) locations. 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 on clinical research standards.

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 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, produce 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, e.g., 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

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

Skills

• Ability to work in a fast-paced environment where deviations from the study protocol are not allowed and meeting timelines is essential
• Adaptability to changing priorities and ability to prioritize on the spot
• Teamwork and strong people skills
• Technology-based data collection and entry into an electronic environment