Clinical Research Associate I

Employer
Tranquil Clinical and Research Consulting Services LLC
Location
Webster, TX
Closing date
Oct 29, 2021

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Sector
Pharmaceutical, Clinical Research Associate
Job Description
Job Title: Clinical Research Associate I (CRA 1)

Department: Clinical Research

Reports to: Project Manager and CRA Manager

Effective Date:

Summary

The Clinical Research Associate (CRA) will be responsible for all necessary activities required for setting up and monitoring a study, completing accurate study status reports, and maintaining study documentation.

The CRA will manage multiple aspects of subject's welfare, including submission of protocol, consent documents for ethics/IRB approval and assist in the preparation of regulatory submissions as requested.

To be successful in this role, the CRA should be able to recognize logistical problems, and initiate appropriate solutions. Ideal candidates will be detail-oriented, have the ability to multitask and be able to collaborate with various role players. The CRA must be able to work independently, be a team player, and proactively problem solve.

As a CRA you will work independently to monitor your study sites, including evaluation, initiation, routine and close out visits.

Qualifications
  • Minimum of 1 year of study experience as a CRA, including at least 1 year of active independent field monitoring experience as a CRA- all types of visits.
  • Bachelor's degree in a life science or related discipline OR RN/BSN with 4 years related experience.
  • Computer Skills required with proficiency in Microsoft Office Suite, including Word, Excel, PowerPoint.
  • Other Skills required:
    1. Deep understanding of ICH GCP Guidelines, FDA Code of Federal Regulations, or local country clinical trial regulations.
    2. Excellent time management and social skills
    3. Highly motivated with a phenomenal eye for detail.

Duties and Responsibilities
  • Implements and monitors the progress of clinical studies at investigative sites
  • Ensures that clinical studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
  • Conducts site visits to assess the qualification of potential investigators, sites, and site staff
  • Initiates studies and instructs site personnel on the proper conduct of studies
  • Conducts routine monitoring visits to oversee conduct of clinical trial and ensure Principal Investigator oversight
  • Provides regular clinical status information to team members and project management
  • Communicates common site trends to Lead CRA and other project team members
  • Performs investigative site file reconciliation and requests any new or updated site-related essential and non-essential documents
  • Reviews essential documents for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project standard operating procedures, and sponsor requirements.
  • Ordering, tracking, and managing IP and trial materials.
  • Overseeing and documenting IP dispensing, inventory, and reconciliation.
  • Ordering, tracking, and managing IP and trial materials.
  • Overseeing and documenting IP dispensing, inventory, and reconciliation.
  • Meeting all deliverables including timely submission and finalization of monitoring visit reports, per SOPs and monitoring plan
  • Travel Requirements: Ability to Travel up to 80% of the month

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