Clinical Research Associate II - Florida - Phase I Job at Fortrea, Daytona Beach, FL

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  • Fortrea
  • Daytona Beach, FL

Job Description

Fortrea's Clinical Pharmacology Team is hiring a CRA 2 with Phase I experience 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: $100-113K

#LI - Remote

Applications will be accepted on an ongoing basis.

Learn more about our EEO & Accommodations request here.

Job Tags

Full time, Part time, Local area, Remote work, Flexible hours,

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