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Clinical Operations Manager

2 months ago

Brooklyn, New York, United States DM Clinical Research Full time
Job Overview

Position: Site Manager

The Site Manager is responsible for ensuring that high-quality research is conducted at designated investigative sites in alignment with sponsor protocols, FDA regulations, and ICH/GCP guidelines. The role focuses on delivering superior quality data to the sponsor while ensuring that study enrollment aligns with or surpasses the expectations of the sponsors and meets the organizational objectives in a timely manner.

Key Responsibilities

  • Complete all necessary DMCR training, including ICH-GCP Certification and IATA Certification, promptly.
  • Maintain an up-to-date understanding of current FDA regulations, ICH-GCP guidelines, organizational SOPs, and assigned study protocols.
  • Oversee the performance and immediate supervision of site staff under the guidance of the Site Director or Director of Site Operations.
  • Ensure all relevant training is completed before the commencement of studies and on an ongoing basis, including:
    • Sponsor-provided and IRB-approved Protocol Training
    • Training on all relevant Protocol Amendments
    • Study-specific Manuals Training as applicable
    • Training on Sponsor-specified EDC and/or IVRS and other relevant electronic systems.
  • Guarantee preparedness for all sponsor and CRO visits related to assigned protocols and ensure timely follow-up on action items.
  • Utilize and implement the most current versions of Protocols, Informed Consents, Study Manuals, and other relevant study documents consistently.
  • Manage clinical trial operations from First Patient First Visit (FPFV) to study closeout, ensuring strict adherence to study protocols, ICH-GCP guidelines, FDA regulations, and organizational SOPs.
  • Ensure data integrity, subject retention, compliance, and timely reporting of study data for assigned protocols.
  • Achieve site objectives by managing staff effectively, facilitating training, and communicating job expectations.
  • Provide coaching, counseling, and disciplinary actions as necessary.
  • Develop, coordinate, and enforce site-specific systems, policies, procedures, and productivity standards.
  • Communicate and implement strategic goals from senior management to the site team.
  • Work towards meeting Sponsor subject enrollment goals for assigned protocols.
  • Strive to meet weekly, monthly, and quarterly objectives for the site.
  • Be prepared for and participate in all required company meetings.
  • Submit necessary administrative documentation in accordance with company timelines.
  • Occasionally attend 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 additional duties as assigned by management.

Qualifications

Education:

  • Bachelor's degree preferred.
  • Advanced degree preferred.

Experience:

  • A minimum of 4 years of experience as a clinical research coordinator, including 2 years in a management role within a clinical research organization.

Certifications:

  • Certified Clinical Research Coordinator (CCRC) or equivalent certification preferred.

Skills and Knowledge:

  • Strong teamwork, organizational, interpersonal, and problem-solving skills with attention to detail.
  • Critical thinking and active listening abilities.
  • Reading comprehension skills for understanding work-related documents.
  • Effective verbal and written communication skills tailored to the audience's needs.
  • Ability to multitask, meet deadlines, and work both independently and collaboratively with interdisciplinary teams.
  • Proficient computer skills in relevant software and clinical systems.
  • Comprehensive knowledge of FDA regulations, ICH-Good Clinical Practices (GCP), and ISOs.
  • Proficient communication skills in English, with bilingual (English/Spanish) abilities preferred.

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