Clinical Research Associate

Piper Companies

United States

Remote

USD 110,000 - 125,000

Full time

6 days ago
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Benefits offered by this job

Medical, dental, vision
401(k)
PTO
Direct-hire opportunity

Job summary

Piper Companies seeks a Clinical Research Associate to support a leading organization within the pharmaceutical/biotechnology industry, located on the West Coast of the United States. Responsibilities include site qualification, initiation, monitoring, and closeout visits while ensuring compliance with ICH-GCP, protocols, and regulatory requirements.

The role involves data review, strong investigator relationships, issue resolution, and extensive travel as needed.

Qualifications

  • 2+ years of independent monitoring experience as a Clinical Research Associate.
  • Bachelor's degree in a scientific, healthcare, or related field preferred.
  • Strong knowledge of ICH-GCP guidelines and clinical trial regulations.
  • Experience within pharmaceutical, biotechnology, or medical device studies preferred.
  • Excellent communication, organization, and problem-solving skills.
  • Ability and willingness to travel frequently, including overnight travel.

Responsibilities

  • Conduct site qualification, initiation, routine monitoring, and closeout visits.
  • Ensure studies are conducted in compliance with ICH-GCP guidelines, protocols, and regulatory requirements.
  • Review source documentation, site records, and data for accuracy and compliance.
  • Build and maintain strong relationships with investigators and site staff.
  • Identify, document, and resolve site issues while supporting overall study execution.
  • Complete monitoring reports and follow-up documentation within required timelines.
  • Travel extensively to clinical research sites as required.

Skills

Independent monitoring experience
Communication
Travel willingness
Regulatory knowledge

Education

Bachelor's degree in science/healthcare

Tools

Veeva Vault
TMF

Job description

Piper Companies is seeking a Clinical Research Associate to support a leading organization within the pharmaceutical/biotechnology industry located within the West or West Coast of the United States.

Responsibilities of the Clinical Research Associate:
  • Conduct site qualification, initiation, routine monitoring, and closeout visits.
  • Ensure studies are conducted in compliance with ICH-GCP guidelines, protocols, and regulatory requirements.
  • Review source documentation, site records, and data for accuracy and compliance.
  • Build and maintain strong relationships with investigators and site staff.
  • Identify, document, and resolve site issues while supporting overall study execution.
  • Complete monitoring reports and follow-up documentation within required timelines.
  • Travel extensively to clinical research sites as required.
Qualifications of the Clinical Research Associate:
  • 2+ years of independent monitoring experience as a Clinical Research Associate.
  • Bachelor's degree in a scientific, healthcare, or related field preferred.
  • Strong knowledge of ICH-GCP guidelines and clinical trial regulations.
  • Experience within pharmaceutical, biotechnology, or medical device studies preferred.
  • Excellent communication, organization, and problem-solving skills.
  • Ability and willingness to travel frequently, including overnight travel.
Compensation for the Clinical Research Associate includes:
  • Pay Rate: 110k-125k/year
  • Comprehensive benefits package including medical, dental, vision, 401(k), and PTO
  • Direct-hire opportunity with long-term career growth

Keywords: Clinical Research Associate, CRA, CRA II, Senior CRA, Clinical Monitoring, Independent Monitoring, Site Management, Site Qualification Visits (SQV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), Closeout Visits (COV), ICH-GCP, FDA Regulations, Clinical Trials, Oncology, Hematology, General Medicine, Vaccines, Medical Devices, Cardiovascular Studies, Pharmaceutical Research, Biotechnology, CRO, Sponsor Studies, Regulatory Compliance, Source Data Verification (SDV), Investigator Sites, Clinical Operations, Patient Safety, Protocol Compliance, Trial Master File (TMF), Veeva Vault, Risk-Based Monitoring, Field-Based CRA, Remote Monitoring, Clinical Site Management, Study Startup, Study Conduct, Clinical Research, Life Sciences, Bachelor's Degree, Travel Required, Direct Hire.

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