Senior Clinical Research Coordinator

1 month ago

Lafayette, United States Sunwise Clinical Research, LLC Full time

Job Description:

We are seeking an experienced and detail-oriented Senior Study Coordinator to join our clinical research team. This role will lead the coordination and management of complex clinical trials, ensuring compliance with regulatory standards and efficient trial operations. The Senior Study Coordinator will work closely with investigators, research staff, and external partners to support high-quality, timely, and reliable data collection.

Key Responsibilities:

  • Study Coordination: Oversee multiple clinical trials, including study start-up, patient enrollment, follow-up, and study closeout, ensuring all milestones are met.
  • Compliance and Protocol Adherence: Ensure trials are conducted in accordance with the protocol, Good Clinical Practice (GCP) guidelines, institutional policies, and applicable regulatory requirements.
  • Data Management: Oversee the collection, entry, and management of clinical trial data, ensuring data integrity, accuracy, and timely reporting to sponsors and regulatory bodies.
  • Patient Interaction: Manage patient recruitment, consent, and follow-up visits; act as the primary contact for patients enrolled in studies.
  • Team Leadership: Provide guidance and mentorship to junior study coordinators and research assistants; facilitate team meetings to review trial status and address challenges.
  • Documentation: Maintain accurate and up-to-date trial documentation, including regulatory binders, informed consent forms, adverse event logs, and protocol deviations.
  • Safety Monitoring: Ensure proper handling, reporting, and documentation of adverse events, protocol deviations, and safety concerns.

Qualifications:

  • Education: Bachelor’s degree in a healthcare or science-related field; Master’s degree or certification in clinical research (e.g., CCRP, CCRC) is preferred.
  • Experience: Minimum of 3-5 years of experience in clinical trial coordination, with at least 1-2 years in a senior or supervisory role.
  • Knowledge: Thorough understanding of clinical trial phases, regulatory compliance, and GCP guidelines.
  • Skills: Strong organizational skills, attention to detail, and the ability to manage multiple priorities. Proficiency in clinical trial management software (CTMS) and electronic data capture (EDC) systems.
  • Interpersonal Abilities: Excellent communication and interpersonal skills, with the ability to work effectively with diverse teams, patients, and external partners.

What We Offer:

  • Competitive Salary based on experience
  • Comprehensive Benefits Package including health, dental, and retirement plans
  • Professional Development Opportunities for ongoing learning and career growth
  • Supportive Work Environment committed to quality research and patient care

If you are an experienced study coordinator looking for a leadership role in a dynamic clinical research setting, we would love to hear from you

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