FSP Sr. Clinical Research Associate II - Denver, CO - Oncology

About the Role

Our FSP team is currently seeking an Oncology Senior Clinical Research Associate (CRA) 2 with 5+ years of monitoring experience residing in the Denver, Colorado area. You will utilize your skills, knowledge, and clinical judgment to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon 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 review.
  • 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, 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.

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.
• 30-50% overnight travel.

Work Environment

Work is performed in an office environment with exposure to electrical office equipment. Frequent travel to clients/site locations with occasional travel both domestic and international.

Physical Requirements

• Ability to sit for extended periods and operate a vehicle safely.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Regular and consistent attendance.
• Varied hours may be required.

Skills

The ideal candidate is comfortable working in an environment that is:

• Fast-paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even a few minutes will create a quality issue.
• Changing priorities constantly: requiring you to prioritize and adapt on the spot.
• Teamwork and people skills: essential for the study to run smoothly.
• Technology-based: data is collected directly into an electronic environment.

Pay

Target pay range: $125,000 - $140,000.