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Open nowPosted 6 days ago

FSP Clinical Research Associate 2 - East Coast - Oncology

Fortrea49 open roles

Where
Durham
Work mode
Remote
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Your applicationOpen nowFSP Clinical Research Associate 2 - East Coast - OncologyFortrea · Durham
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The clock on this job

Early applications get read.

8.1% of postings close within 7 days. Measured by our own scanner across the market. Fortrea postings stay open a median of 4 days.

Share of postings closed within
  1. 1.7%1 day
  2. 3.6%3 days
  3. 8.1%7 days
  4. 15.1%14 days
  5. 34.0%30 days
This job: posted 6 days ago

Fortrea median: 4 days open

The posting

Our FSP team is currently seeking Oncology CRA 2s on the East Coast! 8-10 days on site per month being a mix of onsite and remote.

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 of Clinical Monitoring experience
  • 60% 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: $100-112K

#LI - Remote

Applications will be accepted on an ongoing basis.

Learn more about our EEO & Accommodations request here.

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