Laboratory Technician / Clinical Research Coordinator

Eurofins USA Consumer Product Testing•Austin, TX

22h•Onsite

About The Position

The General Laboratory Technician role is an entry-level position in the Clinical Services department at Eurofins CRL, Inc. The Eurofins CRL, Inc. (ECRL) Texas location serves pharmaceutical, cosmetic and personal care product industries by performing safety, efficacy and consumer perception studies in vivo and in vitro, in compliance with applicable Good Laboratory Practices (GLPs) and Good Clinical Practices (GCPs). The Technician reports directly to the Clinical Services Manager and is involved in a multitude of different testing and lab activities in clinical settings. Testing and techniques include Human Repeat Insult Patch Testing, Clinical Safety-In-Use testing, Bio-instrumental efficacy testing, and more. This position will require heavily on administrative work performed electronically (such as generating study documents, data entry on Excel and Word Doc, reviewing study results, etc) and through physical documents as it relates to onboarding, conducting, and concluding Clinical Research Studies all within a projected timeline.

Requirements

Ability to operate standard and advanced laboratory instrumentation as evidenced through prior work experience.
Experience related to clinical research (HIPAA, screening, obtaining informed consent, etc.)
Experience relating to FDA/USP/EP oversight of cosmetics and topical/oral antiseptics
Strong attention to detail relating to GDP compliant documentation practices and Quality Assurance
Ability to work cooperatively in a team and independently on individual assignments
Ability to interact positively and respectfully with Clinical Study Subjects
Ability to provide clear and effective verbal and written communication
Proficiency in Microsoft Office Suite (Word, Excel, etc.)
Bachelor’s-level degree in a science field, preferably in the biological sciences.

Responsibilities

Maintain a safe, fast-paced, and positive laboratory environment.
Follow all applicable Good Laboratory Practice Regulations.
Follow all protocol and SOPs, reporting any deviations promptly to Study Director.
Note and inform Study Director of any unforeseen circumstances that may affect the quality and integrity of the study.
Follow all applicable Good Clinical Practice Regulations.
Obtain informed consent from human test subjects in a GCP setting.
Obtain background health information from prospective study subjects to evaluate their eligibility to participate in Eurofins CRL, Inc. clinical trials.
Obtain HIPAA Authorization from prospective study subjects.
Coordinate with Principal Investigator to ensure adequate subject recruitment has been met for each study.
Interact directly with clients on an as-needed basis.
Perform delegated duties assigned by Principal Investigator.
Responsible for the technical conduct of assigned tasks.
Follow all protocol and SOPs, reporting any deviations promptly to Principal Investigator.
Responsible for the technical conduct of assigned tasks in the Clinical Services department.
Tasks included in this testing include preparation of study materials, study conduct, and executing clinical studies with human subjects.
Preparation of study materials requires strong attention to detail and organizational skills.
Performing study conduct after adequate training, including patching for sensitization tests, and performing basic dermal evaluations of study subjects.
Performing testing methodologies with clinical subjects involves informed consent of volunteers, eligibility screening, and leading subjects through testing methodologies and study requirements.
Make certain that all experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified.
Data entry involves the ability to work with large excel documents, entering data and performing downstream calculations utilizing excel formulas.
Data review encompasses reviewing data entered in large excel files as well as ensuring all data required of protocol is captured adequately.
Maintain and regularly update resume and training records.
Assist with basic laboratory needs, such as cleaning, organization, inventory management or equipment validation.
Other duties as needed.