Senior Clinical Research Associate

Reports to:    Director, Clinical Affairs

Department:   Clinical

Strategic Focus Areas:

The strategic focus of the Sr. CRA is to ensure that the study is conducted in accordance with the approved protocol; that the study subjects’ rights and privacy are protected; and that the integrity of the conduct of the study is sound and free from falsification or other bias.

 Specific Tactical Responsibilities:

  • Conduct monitoring to verify accuracy of study data vs. source records
  • Ensure HIPAA requirements for patient privacy are met
  • Ensure no study tasks are conducted prior to IRB/EC approval, CA/FDA approval, and formal site activation
  • Work details of study budgets and contracts with sites
  • Generate study documents such as Case Report Forms and CRF completion guidelines
  • Collect study documentation from site such as completed CRFs, Investigator Agreements, Investigator CV’s and licenses, training forms, protocol deviations, queries, adverse event reports, etc.
  • Build and maintain tracking sheets to track progress of sites to initiation, enrollment and screening, interim monitoring, and close-out requirements
  • Maintain documentation in electronic and paper Trial Master Files
  • Maintain close communication with study sites, investigators, and vendors to execute the trial in accordance with the protocol, study timeline, and study budget
  • Conduct Site Qualification, Initiation, Interim Monitoring, and Close-out visits and write corresponding visit reports, as needed
  • Provide oversight of contract monitors including co-monitoring
  • Ensure adverse event reporting is done in accordance with regulatory requirements
  • Verify the accuracy of study results

Job Complexity:

The Sr. CRA role requires detailed knowledge of the clinical indication, the medical status of the patient population, and details of the study device/drug and the protocol. The Sr. CRA must have training and significant experience as a site monitor per FDA requirements.

Supervisory Responsibilities:

No direct reports

Required Qualifications:

  • Bachelor’s degree in the life sciences or health related field or RN
  • Strong working knowledge of guidelines and systems for clinical trial management as well as ICH, FDA, and GCP regulations
  • Travel up to 25% is required

 Desired Experience, Knowledge, and Skills:

  • 2+ years of current clinical trial monitoring experience
  • Medical and clinical knowledge of indications, therapies, and patient population
  • Proven track record of having good sponsor, investigator, site, and vendor relations
  • Excellent interpersonal, verbal, and written communication skills
  • Attention to detail and strong organizational skills
  • Strong computer skills including EDC system experience
  • Excellent interpersonal, verbal, and written communication skills
  • Attention to detail and strong organizational skills
  • Good problem solving skills
  • Ability to establish strong relationships with physicians and study staff
  • Enthusiastic and energetic


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