Clinical Research Associate II, Phase I - Texas/Mid-West

Fortrea; Kansas; On-site; USD 100,000 - 120,000; Full time

Job summary

Fortrea is seeking a Clinical Research Associate to monitor Phase I trials with 1+ years of experience. The role involves site visits, adherence to protocol, data integrity, and SAE reporting across sites in the Kansas/Midwest region.

The candidate will conduct initiation and close-out visits, manage study files, and work closely with vendors. Travel up to 50% is expected, with opportunities to contribute to training and local project coordination.

Qualifications

• University or college degree, or certification in a related allied health profession.
• 1+ years of Clinical Monitoring experience; Phase I experience preferred.
• 40-50% overnight travel requirement.
• Ability to work in a fast-paced environment with strict adherence to protocol.

Responsibilities

• Monitor clinical sites for protocol compliance, data quality, and patient safety.
• Manage site initiation, routine monitoring, and close-out visits; maintain study files.
• Liaise with vendors and coordinate local project activities.
• Ensure informed consent and regulatory compliance across sites.
• Perform CRF review and data validation according to guidelines.
• Assist with training of new staff and act as local client contact as needed.
• Oversee SAE reporting and narratives; manage data integrity in CRFs.

Skills

Clinical Monitoring

Site Monitoring

SAE Reporting

CRF Review

Teamwork

Education

University or college degree

Nursing licensure

Tools

Fortrea systems

Job description

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 Texas or Mid-West (Kansas, Missouri, Nebraska, Iowa, Colorado).WHAT YOU WILL DOYou 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 plansGeneral On-Site MonitoringEnsure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the studyEnsure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirementsEnsure 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 dataResponsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requestedComplete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEsIndependently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by managementAssist with training of new employees, eg. co-monitoringCoordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assignedPerform other duties as assigned by managementRequirementsUniversity 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 experiencePhase I experience40-50% overnight travelThe important thing for us is you are 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 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: $100 - $120KApplications will be accepted on an ongoing basis.Learn more about our EEO & Accommodations request here .