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Orso Health

Senior Clinical Research Coordinator

Clinical Research OperationsUpdated on Nov 10
Full-time

About the Job

Requirements

  • A bachelor's degree in a related field, such as life sciences or nursing, is required.
  • At least five years of clinical research experience, including at least two years as a Clinical Research Coordinator, is required.
  • Strong knowledge of good clinical practice (GCP), FDA regulations, and clinical trial processes is required.
  • Proficiency with clinical trial management systems (CTMS) and electronic data capture (EDC) tools is required.
  • The candidate must be willing to travel frequently between sites.
  • The candidate must be able to stand, walk, and move throughout the clinic for extended periods; occasionally lift up to 25 pounds; bend, stoop, or reach; use hands and fingers frequently for patient care and equipment operation; and have normal or corrected vision and hearing and the ability to respond quickly in a fast-paced clinical environment.

Responsibilities

  • Oversee day-to-day clinical trial operations at various sites, ensuring adherence to study protocols, regulatory compliance, and good clinical practice.
  • Provide training and support to junior Clinical Research Coordinators and site staff on study procedures.
  • Recruit study participants, obtain informed consent, and address participant questions and concerns about the study process.
  • Ensure accurate and timely collection, documentation, and reporting of study data in accordance with regulatory guidelines and sponsor requirements.
  • Maintain regulatory documentation, including Institutional Review Board (IRB) submissions, regulatory binders, and serious adverse event (SAE) reporting.
  • Serve as the primary point of contact between the sponsor, study sites, and internal teams, facilitating communication and resolving issues.
  • Participate in site visits and audits to ensure compliance with study protocols and regulations.

Desired Qualifications

  • Experience in a variety of therapeutic areas.
  • Certification in clinical research, such as ACRP or SOCRA certification.

About the Company

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