Oncology - CAR-T - CRAs & Sr. CRAs - Remote US

📋 Description

• • We are currently seeking Experienced Oncology CRAs to lead and support our Full Service Outsourcing team working with various sponsors.
• • 1+ year of independent CRO/sponsor monitoring required.
• • CAR-T desired.
• • Open to major hub locations across the US.
• • 60-70% travel, 8-10 DOS per month.
• • 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.
• • 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?
• • 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): $105-145K.
• • 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.
• • #LI - Remote.
• • Applications will be accepted on an ongoing basis.
• • Learn more about our EEO & Accommodations request here.