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CRA 2 - Florida - Clinical Pharmacology Services - Phase I

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Offer summary

Qualifications:

University or college degree or certification in a related allied health profession (e.g., nursing licensure), 1+ years of Clinical Monitoring experience, Phase I experience preferred, Must reside in Florida..

Key responsabilities:

  • Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites
  • Ensure the protection of study patients by verifying informed consent procedures and protocol requirements
  • Complete Serious Adverse Event (SAE) reporting and follow up of SAEs
  • Assist with training of new employees and coordinate designated clinical projects as a Local Project Coordinator.

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Fortrea XLarge https://fortrea.com/
10001 Employees
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Job description

Fortrea's Clinical Pharmacology Team is hiring CRA 2s with Phase I experience! We are seeking candidates in Florida.

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)
  • 1+ years of Clinical Monitoring experience
  • Phase I experience preferred
  • Must reside in Florida

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): $105-120K

#LI - Remote

Applications will be accepted on an ongoing basis.

Learn more about our EEO & Accommodations request here.

Required profile

Experience

Industry :
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Teamwork
  • Adaptability
  • Communication

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