Monitoring Excellence Academy - OMEA - Oncology / CAR T & Alzheimer's - CRA 1

Job Title: Monitoring Excellence Academy - OMEA - Oncology / CAR T & Alzheimer's - CRA 1

Job Location: Remote United States

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

Fortrea’s 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 Alzheimer's as a CRC or research nurse. Open to various 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, 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)

• 2+ years as a Study Coordinator or Research Nurse in specified therapeutic areas

• Oncology 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.

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Originally posted on Himalayas