Research Study Supervisor I

2 weeks ago

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

Position Title: Study Manager

A Study Manager plays a crucial role in ensuring that high-quality research is conducted at designated investigative sites, adhering to the sponsor's protocol, FDA Regulations, and ICH/GCP guidelines. The objective is to deliver the highest quality data to the sponsor while ensuring that study enrollment meets or exceeds expectations and that company goals are achieved efficiently.

Key Responsibilities

  • Complete all required training for DMCR, including ICH-GCP Certification and IATA certifications, in a timely manner.
  • Maintain a comprehensive understanding of current FDA regulations, ICH-GCP guidelines, organizational SOPs, and assigned study protocols.
  • Ensure strict adherence to assigned protocols at respective sites.
  • Complete all relevant training prior to the start of the study and continue to update knowledge regularly, including but not limited to:
    • Sponsor-provided and IRB-approved Protocol Training
    • All relevant Protocol Amendments Training
    • Any study-specific Manuals Training as applicable
    • Sponsor-specified EDC and/or IVRS training.
  • Prepare for all relevant sponsor and CRO visits for assigned protocols and ensure timely follow-up on action items.
  • Utilize the most recent versions of Protocols, Informed Consents, Study Manuals, and other relevant study documents at all times.
  • Maintain knowledge of Essential Clinical Trial Documents and manage Investigator Site Binders for assigned protocols.
  • Create and review Source Documents for assigned protocols promptly.
  • Train site teams and support the effective conduct of study subject visits and other protocol-required procedures, documenting these in a timely manner.
  • Enforce ALCOA-C Standards with all clinical trial documentation.
  • Ensure proper reporting of Adverse and Serious Adverse Events and any relevant Safety Information to appropriate authorities as per internal guidelines and regulations.
  • Guarantee data quality, subject retention, compliance, and timely reporting of study data for assigned protocols.
  • Collaborate with cross-functional teams and site teams to ensure study readiness and provide adequate training to site staff prior to First Patient First Visit (FPFV).
  • Manage clinical trials from FPFV to study closeout, ensuring strict adherence to study protocols and all relevant guidelines.
  • Work closely with the Associate Site Director/Site Director to achieve strategic objectives for the site.
  • Assist with staff training and other relevant tasks as assigned by management.
  • Strive to meet subject enrollment goals for assigned protocols.
  • Ensure that weekly, monthly, and quarterly goals are met for respective sites.
  • Be prepared for and participate in all required company meetings.
  • Submit necessary administrative paperwork according to company timelines.
  • Occasionally attend out-of-town Investigator Meetings.
  • Conduct patient consent discussions, ensuring comprehension of medical procedures, risks, benefits, and alternatives.
  • Provide clear explanations of study protocols to ensure patient understanding before obtaining consent.
  • Facilitate effective communication between 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 with a wide range of therapeutic clinical trials preferred.
  • Regulatory research experience is a plus.

Credentials:

  • ACRP or equivalent certification preferred.

Skills:

  • Goal-oriented while maintaining quality standards.
  • Detail-oriented, proactive, and able to take initiative.
  • Strong written and verbal communication skills.
  • Excellent customer service skills.
  • Proficient in English; bilingual (English/Spanish) skills preferred.

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