Clinical Research Associate II, Phase I

Fortrea; Durham (NC); On-site; USD 105,000 - 118,000; Full time

Job summary

Fortrea is seeking a Clinical Research Associate II with 1+ years of on-site monitoring experience to support Phase I studies. The role requires travel (40–50% overnight) and the ability to work within a fast-paced, regulated environment in the United States.

You will monitor study sites, manage visits, ensure proper consent and protocol adherence, review CRFs, generate data queries, and assist training of new staff. Candidates with Phase I experience are preferred.

Qualifications

• University or college degree or related allied health certification.
• 1+ years of clinical monitoring experience.
• Phase I experience preferred.
• Willingness to travel 40-50% overnight.

Responsibilities

• Monitor study sites including routine monitoring, close-out visits, and maintenance of study files.
• Coordinate site management as prescribed in project plans and liaise with vendors.
• Ensure informed consent procedures and protocol adherence.
• Review CRFs and generate data queries with resolution.
• Assist with training of new staff and coordinate local projects.

Skills

Clinical Monitoring

Phase I

Travel

Education

Bachelor's degree

Tools

EDC systems

Job description

Our Phase I team is currently seeking a Clinical Research Associate II with 1+ years of on-site monitoring experience. Ideal candidates would have phase I experience and reside within 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; 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 repo11s, 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, ifapplicable) 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: 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: $105 - $118K

#LI - Remote

Applications will be accepted on an ongoing basis.

Learn more about our EEO & Accommodations request here.