FSP Clinical Research Associate 2 - West Coast & Texas

Fortrea; Deutschland; Vor Ort; EUR 86.000 - 97.000; Vollzeit

Zusammenfassung

Fortrea is seeking a CRA II to monitor clinical sites across the West Coast or Texas, with 2 years of monitoring experience. The role involves on-site and remote work 8-10 days on site per month.

You will conduct site visits, ensure regulatory compliance, manage CRFs, and contribute to SAE reporting and data integrity. Travel expectations include 60% overnight travel to sites domestically.

Qualifikationen

• 2 years of Clinical Monitoring experience.
• University or college degree, or certification in a related allied health profession (e.g. nursing licensure).

Aufgaben

• 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 per regulatory requirements
• Ensure data integrity of CRFs and other data collection tools
• Account for registry management as prescribed in project plans
• Complete SAE reporting and follow-up
• Independently perform CRF review; query generation and resolution
• Assist with training of new employees
• Coordinate designated clinical projects as Local Project Coordinator
• Perform other duties as assigned

Kenntnisse

Clinical Monitoring

Travel

Ausbildung

Bachelor's degree or allied health certification

Jobbeschreibung

Our FSP team is currently seeking a CRA 2 on the West Coast or in Texas with 2 years of monitoring! May consider states west of Texas. 8-10 days on site per month being a mix of onsite and remote.

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)

• 2 years of Clinical Monitoring experience

• 60% 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: $100-112K

#LI - Remote

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