Sr Clinical Research Associate II, Phase I - Florida

Fortrea; Daytona Beach (FL); On-site; USD 115,000 - 140,000; Full time

Job summary

Fortrea in Florida is seeking a Clinical Research Associate with 1+ years of Clinical Monitoring experience to support Phase I trials. You will monitor sites, ensure protocol compliance, and collaborate with study teams.

The role requires travel 40-50% overnight, a related degree or certification, and the ability to manage data quality and safety reporting.

Join a fast-paced, team-oriented environment with strong emphasis on regulatory standards and patient safety.

Qualifications

• 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

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 the proper materials and instructions to safely enter patients into the study
• Ensure informed consent procedures and protocol requirements are adhered to according to regulatory requirements
• Ensure data integrity on Case Report Forms (CRFs) and other data collection tools
• Responsible for registry management as prescribed in the project plans
• Complete SAE reporting and follow up of SAEs
• Independently perform CRF review and query resolution
• Assist with training of new employees
• Coordinate designated clinical projects as Local Project Coordinator
• Perform other duties as assigned by management

Skills

Clinical monitoring

Phase I experience

Travel readiness

Education

University degree or allied health certification

Relevant certification (e.g. nursing licensure)

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 the Florida.

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: $115 - $140K

Applications will be accepted on an ongoing basis.

Learn more about our EEO & Accommodations request here.