Title: Laboratory Manager

Location: Rogers, AR

About us:

ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with expertise in early and late-stage neuroscience drug development. With 20 wholly owned clinical sites and 4 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 400 in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes, and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally.

Job Description:

The Laboratory Manager supervises the Laboratory Coordinators to ensure provision of quality specimen processing, archiving, shipping and effective team performance to meet the goals at ERG/ Laboratory Manager assist with maintaining the lab in a neat and organized fashion while managing the protocol specific sample collection, processing, storage and shipping.

Responsibilities:

• Supervise laboratory coordinators to ensure all study specimens are processed and archived according to protocol specifications.
• Notify the appropriate management staff of missed time-points, insufficient sample collection, improper specimen collection or unusual incidents.
• Oversee and/or prepare the collection tubes, vials, containers, etc. with study and subject identification labels for protocol specific collection time-points.
• Assist in maintaining the specimen processing area is clean, set up according to protocol requirements and that all required supplies are stocked.
• Perform duties of processing, archiving and/or shipping specimens
• Assist in a variety of routine blood drawing procedures to include venipuncture techniques using standard equipment to include vacutainer tubes and sleeves, tourniquets, syringes and butterfly needles, as assigned.
• Ensure appropriate tubes, vials, and containers necessary for specimen collection are used, depending upon tests ordered.
• Must be able to provide top quality care and concurrently handle high levels of stress.
• Clinical skills indicated by level of education, licensure, registration and/or certification.
• Perform study specimen collections and collects clinical data as directed by principal investigator and protocol.
• Serve in rotation as on-call supervisor.
• Facilitate the team process including interdisciplinary communications.
• Participate in collaborative team efforts with other departments.
• Ensure that processing laboratory areas are properly stocked with study supplies (i.e., blood tubes, vials, kits, containers, study flowsheets, etc.)
• Ensure the Laboratory is properly staffed for processing, archiving, and shipping requirements by reviewing study schedules for each specific protocol.
• Ensure accurate maintenance of records with regards to the research project
• Assist in giving accurate and easily accessible research data to the Data Entry department.
• Anticipate, recognize, and resolve issues.
• Recognize the need to seek assistance or inform senior management of specific issues.
• Lead necessary team training efforts for all facets of the laboratory.
• Monitor and maintain temperature logs for the lab.
• Read and understand each protocol in which she/he is involved.
• Keep appraised of the current implementation of OSHA, FDA and GCP/ICH regulations, guidelines, and procedures.
• Follow established guidelines in the collection of clinical data and/or administration of clinical studies.
• Comply with all site and corporate policies and procedures, especially those regarding protocol confidentiality.
• Demonstrate a caring, professional attitude and behavior toward study participants and staff, actively contributing to the well-being and dignity of the clinic.
• Maintain an overall good work attitude, promoting cooperation and professionalism and interactions with other staff members.
• Maintain assigned work areas in a clean, safe condition, and report any potential hazards immediately.
• Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG’s objectives.

Skills and Qualifications:

• Education and experience
  • A minimum of a High School diploma with 5 years of specimen processing and collection experience or professional licensure, Registration and/or Certification in a clinical or allied health field is required with a minimum of one year specimen processing and collection experience in a central laboratory or medical facility.
  • BLS and/or ACLS certification preferred.
  • Phlebotomy certification preferred but not required.
  • Basic computer skills, including knowledge of Microsoft Office, are required.
• Requirements
  • Maintain current licensure, registration and/or certification within educational background.
  • Maintain current BLS and/or ACLS certification.
  • Maintain necessary CEU’s for registration and/or certification.
  • Assist in the training of research staff in laboratory duties at the clinic.
  • Actively participate on site’s ongoing Quality Assurance Program, HIPAA, and Compliance Programs
  • Attend all appropriate team meetings regarding study protocols.
  • Read and understand site's policy and procedures manuals, SOP manual and employee handbook.