Sr Clinical Research Associate, Phase I - MIdwest

Fortrea; Wisconsin; Remote; USD 100,000 - 135,000; Full time

Job summary

Fortrea seeks a Senior Clinical Research Associate with 3+ years of experience to oversee Phase I trials and ensure high-quality data and patient safety across US sites.

The role involves fast-paced study environments, extensive site monitoring, and collaboration with cross-functional teams to meet timelines. Expect 40-50% overnight travel and regulatory oversight as a core duty.

Qualifications

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

Responsibilities

• Monitor study sites including routine monitoring and close-out, maintain study files, and conduct initiation visits.
• Manage site activities per project plans and liaise with vendors.
• Ensure proper staff training and materials for protocol entry and safety procedures.

Skills

Clinical monitoring

Study site coordination

Regulatory compliance

Travel readiness

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, if applicable) 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 - $135K

Remote

Remote

Applications will be accepted on an ongoing basis.

Learn more about our EEO & Accommodations request here.