Clinical Study Coordinator I

2 weeks ago

Houston, Texas, United States DM Clinical Research Full time
Job Overview

Position Summary:

A Study Manager plays a crucial role in ensuring that high-quality research is executed at designated investigative sites, adhering to sponsor protocols, FDA regulations, and ICH/GCP guidelines. The objective is to deliver the highest quality data to the sponsor while meeting or exceeding enrollment expectations and achieving company objectives in a timely manner.

Key Responsibilities:

  • Complete all required training for DMCR, including ICH-GCP Certification and IATA certifications promptly.
  • Maintain an up-to-date understanding of FDA regulations, ICH-GCP guidelines, organizational SOPs, and assigned study protocols.
  • Ensure strict adherence to assigned protocols at respective sites.
  • Participate in all relevant training before the study commences and continue ongoing education, including:
    • Sponsor-provided and IRB-approved Protocol Training
    • Training on all relevant Protocol Amendments
    • Study-specific Manuals Training as necessary
    • Training on Sponsor-specified EDC and/or IVRS and other relevant electronic systems.
  • Prepare for all sponsor and CRO visits, ensuring timely follow-up on action items at respective sites.
  • Utilize the most current versions of Protocols, Informed Consents, Study Manuals, and other relevant study documents at all times.
  • Maintain a working knowledge of Essential Clinical Trial Documents and manage Investigator Site Binders for assigned protocols.
  • Create and review Source Documents for assigned protocols in a timely manner.
  • Train site teams and support the effective conduct of study subject visits and all relevant protocol-required procedures, documenting these actions promptly.
  • Enforce ALCOA-C Standards across all clinical trial documentation.
  • Ensure proper reporting of Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities in accordance with internal guidelines, Sponsor, IRB, and ICH-GCP Guidelines.
  • Oversee data quality, subject retention, compliance, and timely reporting of study data for assigned protocols.
  • Collaborate with cross-functional teams and site teams to ensure readiness for study initiation and provide adequate training to all relevant site staff prior to First Patient First Visit (FPFV), continuing support for successful trial execution.
  • Manage clinical trials from FPFV to study closeout, ensuring strict adherence to study protocols, relevant manuals, ICH-GCP Guidelines, FDA Regulations, ALCOA-C standards, and organizational SOPs.
  • Work closely with the Associate Site Director/Site Director to achieve strategic site goals.
  • Assist with staff training and other relevant tasks as assigned by the Associate Site Director/Site Director.
  • Strive to meet Sponsor enrollment goals for assigned protocols.
  • Ensure weekly, monthly, and quarterly goals are met for respective sites.
  • Attend all required company meetings and submit necessary administrative paperwork in a timely manner.
  • Occasionally participate in out-of-town Investigator Meetings.
  • Conduct patient consent discussions, ensuring understanding of medical procedures, risks, benefits, and alternatives.
  • Provide clear explanations of study protocols to ensure patient comprehension before obtaining consent.
  • Facilitate effective communication among patients, healthcare providers, and research staff.
  • Perform any other duties as assigned by management.

Qualifications:

Education:

  • High School Diploma or equivalent required.
  • Bachelor's degree preferred.
  • Foreign Medical Graduates preferred.

Experience:

  • Minimum of 5 years of experience in Clinical Research.
  • Supervisory experience preferred.
  • Experience across a wide range of therapeutic clinical trials preferred.
  • Regulatory research experience is a plus.

Credentials:

  • ACRP or equivalent certification preferred.

Skills and Knowledge:

  • Goal-oriented while maintaining a focus on quality.
  • Detail-oriented, proactive, and able to take initiative.
  • Strong written and verbal communication skills.
  • Excellent customer service abilities.
  • Proficient in English communication, both verbal and written.
  • Proficiency in bilingual communication (English/Spanish) is preferred.

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