Clinical Research Associate II, Phase

Position: Clinical Research Associate II, Phase I

Our Phase I team is currently seeking a Clinical Research Associate with 1+ years of experience. Ideal candidates would have phase I experience and reside in the Midwest.
What You Will Do

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.
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; 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 repo
11s, 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.
Requirements
• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure).
• 1+ years of Clinical Monitoring experience.
• Phase I experience.
• 40–50% overnight travel.

The important thing for us is you are comfortable working in an environment that is:
• Fast paced: no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue.
• Changing priorities constantly asking you to prioritize and adapt on the spot.
• Teamwork and people skills are essential for the study to run smoothly.
• Technology based. We collect our data directly into an electronic environment.
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.
• Target Pay Range: $105 – $118K
Remote

Applications will be accepted on an ongoing basis.

Learn more about our EEO & Accommodations request here.
#J-18808-Ljbffr