Clinical Research Associate II

$66,000 - $80,000/Yr

CPC Clinical Research - Aurora, CO

posted 3 days ago

Full-time - Mid Level
Remote - Aurora, CO
Professional, Scientific, and Technical Services

About the position

We are looking for a Clinical Research Associate II to join our team! In this position you will travel to sites conducting clinical trials to ensure all activities are in compliance with the protocol, federal regulations and ICH-GCP (Good Clinical Practice) guidelines. You will conduct various monitoring visits, oversee drug accountability, collect and maintain investigator regulatory documents, and ensure proper maintenance of required records for monitoring activities. Additionally, you will help produce study materials, assist with the selection of qualified sites and investigators, develop and present materials for investigator meetings, and provide training to other CRAs and staff at selected research sites.

Responsibilities

  • Travel to sites conducting clinical trials to ensure compliance with protocol, federal regulations, and ICH-GCP guidelines.
  • Conduct Site Evaluation Visits, Site Initiation Visits, Routine Monitoring Visits, and Close-out Visits.
  • Oversee drug accountability, storage, and disposition at investigative sites.
  • Collect and maintain investigator regulatory documents.
  • Conduct Site Endpoint Evaluation Visits when required by contract.
  • Ensure proper maintenance of required records for monitoring activities and regulatory documents per CPC requirements.
  • Help produce study materials, including Case Report Forms, Study Procedure Manuals, and source documents.
  • Assist with the selection of qualified sites and investigators for participation in research protocols.
  • Develop and present materials for investigator meetings and sponsor/CRO training.
  • Provide training to other CRAs and staff at selected research sites.

Requirements

  • Nursing or bachelor's degree preferred but not required.
  • Minimum of three years of experience in clinical trials research.
  • At least one year experience as a CRA.
  • Demonstrated mastery of CRA I responsibilities.
  • Thorough knowledge of Good Clinical Practice guidelines and applicable FDA and ICH regulations.
  • Understanding of the drug development process.
  • Intermediate level of proficiency in MS Office.
  • Experience with EDC and CTMS strongly preferred.
  • Good interpersonal communication skills, good organizational skills, and great attention to detail.
  • Ability to complete tasks accurately and timely with minimal supervision.
  • Ability to discern priorities to accomplish day-to-day tasks.
  • Ability to manage conflicts and resolve problems effectively.
  • Ability and willingness to travel up to 60%.

Benefits

  • Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
  • Matching 401(k) plan (dollar for dollar up to 4% of eligible compensation, fully vested immediately)
  • 11 paid holidays
  • 15 - 25 vacation days based on years of service
  • Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours)
  • In-suite exercise and relaxation room
  • Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)
  • Flexible and remote work schedules
© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service