Careers

Clinical Research Associate II

Position Scope:

The Clinical Research Associate (CRA) II will assist the Clinical Project Manager in the conduct of clinical trials.

Specific Responsibilities:

  • Conduct independent monitoring to verify accuracy of study data vs. source records
  • Ensure HIPAA requirements for patient privacy are met
  • Generate and collect study documentation such as consent forms, Essential Documents, Case Report Forms and Investigator Agreements
  • Tracks progress of sites to initiation, enrollment and screening, interim monitoring and close out requirements
  • Ensure no study tasks are conducted prior to IRB/EC approval, CA/FDA approval, and formal site activation
  • Liaise with sites on study budgets and contracts with sites
  • Review Serious Adverse Event (SAE) narratives with sites and medical monitor; Ensure adverse event reporting is done in accordance with regulatory requirements
  • Maintain documentation in electronic and paper Trial Master Files
  • Maintain close communication with study sites, investigators, and vendors
  • Organize, conduct and report on Site Qualification, Site Initiation, Interim Monitoring, and Close-out visits
  • Verify the accuracy of study results
  • Identify and resolve site issues
  • Manage all aspects of relationship and operational activities for designated clinical investigational sites
  • Provide oversight of contract monitors to include co-monitoring
  • Participate in other duties and activities as assigned

Job Complexity:

Exercises judgment within defined parameters and policies.  Job requires maintenance of up-to-date knowledge of all applicable regulations and guidance.

Supervisory Responsibilities: 

None

Required Qualifications:

  • Bachelor’s degree in the life sciences
  • 2+ years Registered Nurse or other relevant experience
  • Demonstrated detailed knowledge of guidelines, systems for clinical trial management and of ICH GCP, FDA, and international regulations and practices
  • Travel from 25%-75% may be required

Desired Experience, Knowledge, and Skills:

  • 2+ years of current clinical trial monitoring experience
  • Strong medical and clinical knowledge of indications, therapies, and patient population
  • Proven track record of having good sponsor, investigator, site, and vendor relations
  • 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
  • Enthusiastic and energetic

 

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