Sr Clinical Research Associate II, Phase I

Fortrea; United States; Remote; USD 100,000 - 130,000; Full time

Job summary

Fortrea seeks a Senior Clinical Research Associate with 3+ years of experience to support Phase I trials in the United States. You will monitor clinical sites, ensure data integrity, and uphold regulatory standards.

The role requires 40-50% overnight travel, collaboration with study teams, and the ability to respond to emergencies per clinical research protocols. A university degree or allied health certification is expected.

Qualifications

• 3+ years of clinical monitoring experience.
• Phase I experience required.
• University or college degree or allied health certification.

Responsibilities

• Monitor all aspects of study sites and ensure regulatory compliance.
• Manage data integrity and SAE reporting.
• Provide training to new employees and coordinate local projects.

Skills

Clinical monitoring

Phase I experience

Teamwork

Travel willingness

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; 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)
• 3+ 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: $100 - $130K

#LI - Remote

Applications will be accepted on an ongoing basis.

Learn more about our EEO & Accommodations request here.