Laboratory Director

Ergclinical; Miami, Northern (FL, KY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Evolution Research Group in Miami, FL seeks a Laboratory Director to oversee specimen processing, archiving, and shipping while leading a team of laboratory assistants. The role ensures quality control, adherence to protocol specifications, and effective interdepartmental communication within a high-demand setting.

The position requires a strong background in laboratory operations, regulatory compliance, and the ability to manage stress while maintaining patient and staff safety.

Qualifications

• Minimum of a High School diploma with 5 years of specimen processing and collection experience, or professional licensure/certification in clinical/health field.
• BLS and/or ACLS certification preferred.
• Phlebotomy certification preferred but not required.

Responsibilities

• Supervise laboratory assistants to ensure specimens are processed and archived per protocol.
• Notify management of missed time-points or irregularities in sample collection.
• Prepare collection tubes and labels for protocol-specific time-points.
• Maintain stocked processing areas and ensure supplies are available.
• Perform processing, archiving, and shipping of specimens.
• Assist in venipuncture procedures using standard equipment when assigned.
• Ensure correct tubes and containers are used for each test.
• Provide care under stress and maintain professional conduct with staff and participants.
• Read and understand study protocols and regulations (OSHA, FDA, GCP/ICH).
• Lead team training for Pharmacokinetic Laboratory operations.

Skills

Microsoft Office

Bilingual

Education

High School diploma or equivalent

Clinical licensure/certification

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Laboratory Director

Full Time CPMI-Clinical Pharmacology Miami, Miami, FL, US

Salary Range: $90,000.00 To $120,000.00 Annually

About Company:

Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I-IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.

Why join us?

We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.

Job Description:

The Laboratory Director supervises the laboratory assistants to ensure provision of quality specimen processing, archiving, shipping, and effective team performance to meet site goals.

Responsibilities:

• Supervise laboratory assistants to ensure all study specimens are processed and archived according to protocolspecifications.
• Notify the appropriate management staff of missed time-points, insufficient sample collection, improper specimen collection or unusualincidents.
• 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 arestocked.
• 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, asassigned.
• Ensure appropriate tubes, vials and containers necessary for specimen collection are used, depending upon testsordered.
• Must be able to provide top quality care and concurrently handle high levels ofstress.
• Clinical skills indicated by level of education, licensure, registration and/orcertification.
• Perform study specimen collections and collects clinical data as directed by principal investigator andprotocol.
• Serve in rotation as on-callsupervisor.
• Facilitate the team process including interdisciplinarycommunications.
• Participate in collaborative team efforts with otherdepartments.
• Ensure that processing laboratory areas are properly stocked with study supplies (i.e., blood tubes, vials, kits, containers, study flowsheets, etc.)
• Ensure PK Laboratory is properly staffed for processing, archiving, and shipping requirements by reviewing study schedules for each specificprotocol.
• Ensure accurate maintenance of records with regards to the research project
• Assist in giving accurate and easily accessible research data to the Data Entrydepartment.
• Anticipate, recognize, and resolveissues.
• Recognize the need to seek assistance or inform senior management of specificissues.
• Lead necessary team training efforts for all facets of the Pharmacokinetic Laboratory
• Read and understand each protocol in which she/he isinvolved.
• Keep appraised of the current implementation of OSHA, FDA and GCP/ICH regulations, guidelines, andprocedure.
• Follow established guidelines in the collection of clinical data and/or administration of clinicalstudies.
• Comply with all site policies and procedures, especially those regarding protocolconfidentiality.
• Demonstrate a caring, professional attitude and behavior toward study participants and staff, actively contributing to the well-being and dignity of theclinic.
• Maintain an overall good work attitude, promoting cooperation and professionalism and interactions with other staffmembers.
• Maintain assigned work areas in a clean, safe condition, and report any potential hazardsimmediately.
• 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 a knowledge of Microsoft Office, arerequired.
  • Bilingual skills are preferred but notrequired.
• Requirements
  • Maintain current licensure, registration and/or certification within educational background.
  • Maintain current BLS and/or ACLScertification.
  • Maintain necessary CEU’s for registration and/orcertification.
  • Assist in the training of Pharmacokinetic Laboratory Staff in duties at theclinic.
  • Actively participate on site’s ongoing Quality Assurance Program, HIPAA, and Compliance Programs
  • Attend all appropriate team meetings regarding studyprotocols.
  • Read and understand policy and procedures manuals, SOP manual and employee handbook.