Variable Hours Officer - Cardiology

Responsibilities

• Clinical Research Responsibilities:
  • Screen participants for study eligibility and accurately enroll them in various databases.
  • Perform simple study procedures with accuracy.
  • Understand the structure of study protocols and interpret study requirements to ensure compliance.
  • Follow proper documentation techniques as outlined in the ICH-GCP guidelines.
  • Process subject reimbursement using pcards.
  • Retrieve and utilize information from electronic medical records (EMR) and databases/CTMS/EDC.
  • Maintain essential regulatory documents as required.
  • Assist the research coordinator in the conduct of Site Initiation Visits (SIV) and attend monitor visits and audits.
• Data Coordination Responsibilities:
  • Collect basic demographic information during study visits.
  • Enter data into forms (CRFs) on paper, databases, or electronic data capture systems (EDCs).
  • Assist in collecting external medical records and radiology CDs as assigned.
  • Administer minimal risk consents independently or complex consents under supervision.
  • Verify the accuracy of own work and resolve simple queries.
  • Conduct surveys and questionnaires.
  • Perform concomitant medications abstraction.
  • Build patient research study charts.
  • Assist in quality control efforts, such as reviewing consents for signatures.
• Regulatory Coordination Responsibilities:
  • Collaborate with regulatory support to collect essential documents and maintain the regulatory binder (e.g., CVs, MD licenses, lab certifications, IRB rosters, lab norms).
  • Assist with adverse events (AEs) and serious adverse events (SAEs).
  • Follow proper documentation techniques as outlined in the ICH-GCP guidelines.
• Administrative Responsibilities:
  • Demonstrate an understanding of the clinical research objectives associated with the program.
  • Communicate with study participants by sending study correspondence via mail or email.
  • Schedule subjects for research visits and follow-up appointments.
  • Monitor study calendar for completion of study procedures.
  • Manage study supply inventory.
  • Utilize documents and systems to track recruitment and retention of participants.
  • Work with regulatory support to maintain the regulatory binder.

Qualifications

• Bachelor's degree in Health Science or equivalent in education, training and experience.
• Familiarity with medical terminology.
• Ability to communicate effectively with staff and faculty members at all levels.
• At least two years of related experience.
• Knowledge of university policies and procedures.
• Previous experience working in a large and complex healthcare setting.