Sr Clinical Research Associate, Phase I - MIdwest

Fortrea; Michigan; Remote; USD 100.000 - 135.000; Vollzeit

Zusammenfassung

Fortrea is seeking a Senior Clinical Research Associate (CRA) with 3+ years of experience to support Phase I studies in the United States. You will monitor sites, ensure patient safety, and maintain data integrity while collaborating with cross-functional teams.

The role requires 40–50% overnight travel, on-site and remote coordination, and training of new staff. You will handle initiation visits, ongoing monitoring, SAE reporting, and data queries per protocol.

Qualifikationen

• 3+ years of Clinical Monitoring experience.
• Phase I experience.
• University or college degree, or certification in a related allied health profession from an appropriately accredited institution.

Aufgaben

• Monitor study sites, perform routine visits, and manage study files.
• Ensure informed consent and protocol adherence per regulations.
• Review CRFs and resolve data queries with data management teams.
• Coordinate site activities and liaise with vendors as needed.
• Assist training of new staff and coordinate local projects.
• Oversee registry management and SAE reporting.
• Travel 40–50% overnight as required by project needs.

Kenntnisse

Clinical Monitoring

Phase I experience

Overnight travel

Ausbildung

Bachelor's degree or related allied health certification

Jobbeschreibung

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.