Laboratory Services Manager

2 weeks ago

Charleston, West Virginia, United States Alcanza Clinical Research Full time
Job Overview

Alcanza Clinical Research is a dynamic and expanding organization engaged in multi-site, multi-phase clinical trials across various therapeutic areas, including vaccine research, neurology, dermatology, psychiatry, and general medicine. We are committed to maintaining high standards in clinical research and laboratory operations.

Position Summary

The Laboratory Services Manager is responsible for overseeing the execution of laboratory protocols and ensuring comprehensive management of laboratory operations in alignment with GCP, ICH, FDA, and HIPAA regulations, as well as company policies and procedures.

Key Responsibilities

Essential Duties:

  • Lead the overall management of laboratory functions, staff, and processes, focusing on efficiency, patient safety, and compliance with protocols and regulations.
  • Oversee the inventory management of both general and study-specific laboratory supplies, ensuring readiness for new study initiations.
  • Manage specimen shipments to central laboratories, ensuring adherence to proper shipping protocols.
  • Assist in the collection and processing of specimens in accordance with trial specifications, as required.
  • Supervise temperature monitoring systems for various storage conditions at all laboratory sites, maintaining thorough documentation.
  • Coordinate the calibration of laboratory equipment and maintain accurate logs and reports.
  • Ensure compliance with OSHA regulations and manage medical waste disposal and vendor relationships.
  • Monitor expiration dates of laboratory supplies and equipment.
  • Oversee the procurement and management of dry ice, optimizing costs through efficient shipping practices.
  • Manage personnel activities, including recruitment, performance evaluations, employee development, and conflict resolution.
  • Oversee staff scheduling, timekeeping, and training initiatives to meet operational demands.
  • Assist in the development and revision of laboratory standard operating procedures (SOPs).
  • Complete required training in GCP and IATA as necessary.
  • Participate in site initiation visits and fulfill sponsor training requirements.
  • Support additional clinical research activities, including electronic data capture and quality assurance reviews, as needed.
  • Maintain compliance with company SOPs, FDA regulations, and GCP guidelines.
  • Uphold confidentiality regarding patient and company information.
  • Perform other related duties as assigned.
Qualifications

Minimum Requirements: An Associate's degree in a relevant scientific field or certification in Medical Assisting or Phlebotomy, combined with at least 5 years of related experience, or an equivalent combination of education and experience. Proficiency in phlebotomy and basic laboratory techniques is essential. Prior management experience is preferred. Bilingual proficiency in English and Spanish is advantageous. BLS certification is preferred.

Required Skills:
  • Proficient in Microsoft Office applications, electronic health records, and web-based tools, with a typing speed of 40+ wpm.
  • Strong organizational, time management, problem-solving, and project management abilities.
  • Excellent written and verbal communication skills.
  • Effective interpersonal skills and the ability to collaborate with diverse stakeholders.
  • Capability to manage multiple tasks and adapt to changing priorities.
  • Professional demeanor, self-motivated, and a strong work ethic.
  • High level of integrity and reliability.
  • Ability to work independently and proactively identify and resolve issues.
  • Skilled in handling sensitive information confidentially and in compliance with HIPAA regulations.
Benefits
  • Full-time employees working a minimum of 30 hours per week are eligible for benefits, with coverage commencing on the first day of the month following hire.
  • Comprehensive benefits package includes medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match.

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