Laboratory Director

Laboratory Director

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.

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 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 PK 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 Pharmacokinetic Laboratory
• 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 procedure.
• Follow established guidelines in the collection of clinical data and/or administration of clinical studies.
• Comply with all site 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:

• 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, are required.
• Bilingual skills are preferred but not required.