Monitoring Excellence Academy Oncology CART Ophthalmology CRA 1 Central or West

Fortreas Monitoring Excellence Academy is hiring!! We are seeking strong Oncology or Ophthalmology Clinical Research Coordinators or Research Nurses with 2 years of current experience. Must have 2 years of Oncology CAR T or Ophthalmology experience as a CRC or research to various Central or West coast hub locations around the US and French Speaking candidates in Montreal Canada. Must be willing to travel 65-70%.

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 -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 as a Study Coordinator or Research Nurse in specified therapeutic areas
• Oncology or Ophthalmology experience is strongly desired ; CAR T a plus
• 60-70% 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: $80-90K

#LI - Remote

Applications will be accepted on an ongoing basis.

Learn more about our EEO & Accommodations request here.