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

Fortrea; Illinois; On-site; USD 105,000 - 140,000; Full time

Benefits offered by this job

401(k)

Paid time off (PTO)

Flexible travel

Professional development

Job summary

Fortrea seeks Experienced General Medicine Sr. CRAs to lead and support our Full Service Outsourcing team in major US hub locations, with 60-70% travel and 8-10 days of travel per month. You will monitor sites, maintain study files, and respond to emergencies based on clinical research standards.

The role requires 1-3 years of clinical monitoring experience and a related degree or certification. You will work across multiple sites, coordinate with vendors, and support project teams in a

Qualifications

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

Responsibilities

• Oversee all aspects of site monitoring including initiation, routine visits, close-out, and file maintenance.
• Manage site relationships and liaise with vendors per project plans.
• Ensure informed consent and protocol adherence per regulatory requirements.

Skills

Clinical Monitoring

Site Management

Regulatory Compliance

Team Leadership

Education

Bachelor's degree or allied health certification

Tools

Electronic data capture (EDC) systems

Job description

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

Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to:

• 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

Learn more about our EEO & Accommodations request here.