Position Overview
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 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; monitor data for missing or implausible data.
* Responsible for registry management as prescribed in the project plans and 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 Fortera or client data management systems.
* 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).
* 1+ years of Clinical Monitoring experience.
* Phase I experience.
* 40-50% overnight travel.
Physical Requirements
* Ability to sit for extended periods and operate a vehicle safely.
* Repetitive hand movement of both hands with ability to make fast, simple, repeated movements of 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 objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
* Regular and consistent attendance.
* Varied hours may be required.
Environment & Culture
* Fast paced; no deviations from the study protocol allowed; meeting timelines is critical.
* Changing priorities constantly, requiring prioritization and adaptation on the spot.
* Teamwork and people skills essential for the study to run smoothly.
* Technology based; data is collected directly into an electronic environment.
* Work performed in an office environment with exposure to electrical office equipment.
* Frequent travel to clients/site locations, occasional domestic and international travel.
Compensation
Target Pay Range: $105 - $118K
EEO & Accommodations
Learn more about our EEO & Accommodations request here.
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