Sr. CRA II - General Medicine - East Coast or Mid-West

Fortrea; South Dakota; Presencial; USD 105.000 - 140.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical & Dental & Vision

401(k)

Paid time off

Employee recognition awards

ERGs

Target pay range: $105k–$140k

Descripción de la vacante

Fortrea seeks an Experienced General Medicine Sr. CRA to lead and support our Full Service Outsourcing team in the United States. This role involves high travel, with 60-70% travel, and open access to major hub locations across the country.

You will monitor study sites, ensure protocol adherence, manage data quality, and train staff while coordinating with vendors and clients to keep trials on track. Remote options may exist in designated hubs, but travel remains central.

Formación

• University or college degree, or allied health certification.
• 1-3 years of clinical monitoring experience.
• Open to various hub locations within the United States.

Responsabilidades

• Monitor clinical sites, conduct routine visits, close-out visits, maintain study files and liaise with vendors.
• Perform site management as prescribed in project plans.
• General on-site monitoring activities.
• Ensure staff receive proper materials and instructions to safely enter patients into the study.
• Verify informed consent procedures and protocol requirements to protect study patients.
• Ensure data integrity on CRFs and other data collection tools; review data for missing or implausible entries.
• Undertake feasibility work and registry management as requested; assist with training of new staff.
• Coordinate clinical projects as Local Project Coordinator and act as a client contact when assigned.

Conocimientos

Clinical Monitoring

Educación

Bachelor's degree or allied health certification

Descripción del empleo

We are currently seeking Experienced General Medicine Sr. CRAs to lead and support our Full Service Outsourcing team. Open to major hub locations within the United States. 60-70% travel, 8-10 DOS per month.

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)
• 1-3 years of Clinical Monitoring experience
• Open to various hub locations

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.

What do you get?

Benefits

• Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)
• 401(K)
• Paid time off (PTO) – Flex Plan
• Employee recognition awards
• Multiple ERG’s (employee resource groups)
• Target Pay Range (based on title): $105-140K

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.

- Remote