Sr Clinical Research Associate, Phase I - MIdwest

About the role

Our Phase I team is currently seeking a Senior Clinical Research Associate with 3+ years of experience. Ideal candidates would have phase I experience and reside in the U.S. 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. Work is performed in an office environment with exposure to electrical office equipment, with frequent travel to client/site locations and occasional domestic and international travel. Physical requirements include the ability to sit for extended periods and operate a vehicle safely, repetitive hand movement with fast, simple repeated movements of the fingers, hands, and wrists, occasional crouching or stooping with frequent bending and twisting of the upper body and neck, ability to access and use a variety of in‑house and off‑the‑shelf computer software, light to moderate lifting and carrying (up to 15‑20 lbs) of objects such as luggage and a laptop, and regular and consistent attendance with varied hours as required.

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 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.
  • 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).
• 3+ years of Clinical Monitoring experience.
• Phase I experience.
• 40‑50% overnight travel.
• Comfortable working in a fast‑paced environment where no deviations from the study protocol are allowed, and not meeting a timeline for even a few minutes will create a quality issue.
• Able to handle changing priorities, constantly prioritizing and adapting on the spot.
• Strong teamwork and people skills essential for the study to run smoothly.
• Technology‑based work environment; data collected directly into an electronic environment.

Pay

Target Pay Range: $100 - $135K - Remote