CRA 1 Trainees - Daytona Beach, FL ; Dallas, TX ; Madison, WI & Mid-West US - CPS - Phase I

Fortrea; Orlando, Daytona Beach (FL, FL); Remote; USD 85,000 - 90,000; Full time

Job summary

A leading company in clinical research is seeking CRA 1s with Phase I experience. You will manage study site monitoring, ensuring data integrity and compliance with regulatory requirements. Candidates must have a related degree and clinical monitoring experience. Comprehensive benefits are offered, including medical and paid time off.

Benefits

Medical, Dental, Vision, Life, STD/LTD insurance

Paid time off (PTO) - Flex Plan

Employee recognition awards

Multiple Employee Resource Groups (ERGs)

Qualifications

• 6 months of clinical monitoring experience or 2 years of study coordinator experience required.
• Phase I experience preferred.

Responsibilities

• Manage study site monitoring and ensure data integrity.
• Perform on-site monitoring and oversee site management.
• Complete SAE reporting and assist with training new employees.

Skills

Clinical Monitoring

Teamwork

Data Integrity

Education

University or college degree

Certification in allied health profession

Job description

Fortrea's Clinical Pharmacology Team is hiring CRA 1s with Phase I experience!

We are seeking candidates in the following locations:

• Madison, WI
• Mid-West (OK, KS, MO, NE, IA, CO, WY)

What You Will Do

You will utilize your skills, knowledge, and clinical judgment to provide a high standard of care for participants in clinical trials and respond to emergency situations based on clinical research standards.

Responsibilities

• Manage all aspects of study site monitoring, including routine monitoring, close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, liaising with vendors, and other duties as assigned.
• Oversee site management as prescribed in project plans.
• Perform general on-site monitoring.
• Ensure study staff have received proper materials and instructions for patient entry.
• Protect study patients by verifying informed consent procedures and protocol adherence according to regulatory requirements.
• Ensure data integrity on CRFs or other data collection tools by monitoring source documents for missing or implausible data.
• Manage registry activities as prescribed in project plans and undertake feasibility work when requested.
• Complete SAE reporting, including producing reports, narratives, and follow-ups.
• Perform CRF review, query generation, and resolution following data review guidelines.
• Assist with training new employees, such as co-monitoring.
• Coordinate clinical projects as a Local Project Coordinator and act as a local client contact as assigned.
• Perform additional duties as assigned by management.

Requirements

• University or college degree, or certification in a related allied health profession (e.g., nursing licensure).
• 6 months of clinical monitoring experience or 2 years of study coordinator experience or equivalent.
• Phase I experience preferred.
• Must reside in one of the listed locations.

Work Environment

We value candidates comfortable working in a fast-paced environment with changing priorities, where teamwork and people skills are essential. Our environment is technology-based, with data collected electronically.

What You Get

Eligible employees working 20 or more hours per week may receive comprehensive benefits including:

• Medical, Dental, Vision, Life, STD/LTD insurance
• Paid time off (PTO) - Flex Plan
• Employee recognition awards
• Multiple Employee Resource Groups (ERGs)
• Target pay range: $85-90K

#LI - Remote

Applications are accepted on an ongoing basis. Learn more about our EEO & Accommodations policy here.

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