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Fortrea

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

RemoteUnited States only
Published
Role
Research
Experience
Senior
$105k–$145k/yr
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Open to US only. Set where you work from to check your eligibility.

No BS summary

Experienced Oncology CRA/Sr. CRA for remote US role with 1+ year independent CRO/sponsor monitoring. Must be open to major hub locations across the US and 60–70% travel, 8–10 DOS per month. CAR-T experience desired.

What you'll do

  • Utilize 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.
  • 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.
  • Perform other duties, as assigned.
  • Responsible for all aspects of site management as prescribed in the project plans.
  • 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 reports, 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.
  • May act as a local client contact as assigned.
  • Perform other duties as assigned by management.

What they require

  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution, e.g. nursing licensure.
  • 1+ years of Clinical Monitoring experience.
  • 1+ year of independent CRO/sponsor monitoring required.
  • Preferred: Oncology experience is desired.
  • Preferred: CAR-T desired.
  • Open to various hub locations.
  • Open to major hub locations across the US.
  • 60-70% travel, 8-10 DOS per month.
  • Comfortable working in a fast paced environment where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue.
  • Comfortable with changing priorities constantly asking you to prioritize and adapt on the spot.
  • Teamwork and people skills are essential for the study to run smoothly.
  • Comfortable working in a technology based environment.
  • 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 objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
  • Regular and consistent attendance.
  • Varied hours may be required.

Benefits

  • Medical insurance
  • Dental insurance
  • Vision insurance
  • Life insurance
  • STD/LTD
  • 401(K)
  • Paid time off (PTO) – Flex Plan
  • Employee recognition awards
  • Multiple ERG’s (employee resource groups)

one of the world´s largest and longest-established early-phase clinical research organizations

HealthcareEnterprisefortrea.com

What people say about this company

2.9/ 5

$105k–$145k/yr