Sr Clinical Research Associate II, Phase I

FTCRUMAD Fortrea Clinical Research Unit Inc.; North Carolina; Remote; USD 100,000 - 130,000; Full time

Job summary

Fortrea Clinical Research Unit Inc. is seeking a Senior Clinical Research Associate with 3+ years of experience, ideally with Phase I exposure, to join our Phase I team in the United States.

You will monitor clinical sites, ensure protocol adherence, and contribute to high-quality data across studies. You will manage site activities, coordinate with vendors, and support training while traveling up to 40-50% as needed.

Qualifications

• University degree or allied health certification required.
• 3+ years of Clinical Monitoring experience.
• Phase I experience and 40–50% overnight travel.

Responsibilities

• Monitor all aspects of study sites including routine monitoring and close-out.
• Maintain study files and conduct pre-study and initiation visits.
• Liaise with vendors and oversee site management per project plans.
• Perform SAE reporting and data review per guidelines.
• Coordinate designated clinical projects as Local Project Coordinator and act as client contact as assigned.
• Assist with training of new employees and support registry management per plans.

Skills

Clinical Monitoring

Phase I experience

Overnight travel

Education

University degree or allied health certification

Job description

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.

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.
• Responsible for all aspects of site 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.
• Responsible for all aspects of registry 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 monitoring.
• Monitor data for missing or implausible data.

Requirements

The 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.

• 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.

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 of 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

Target Pay Range: $100 - $130K

Remote Applications will be accepted on an ongoing basis.

Learn more about our EEO & Accommodations request here.

At Fortrea, we're all about turning the "impossible" into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.