Clinical Operations Technician - Temporary at Autonomous Medical Devices Incorporated

Santa Ana, California, United States -

Full Time

Start Date

Immediate

Expiry Date

13 Jun, 26

Salary

22.0

Posted On

15 Mar, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Studies Support, Sample Management, Record Keeping, Molecular Biology Testing, PCR, RT-PCR, BSL-2 Lab, Regulatory Compliance, Good Clinical Practice, Data Confidentiality, Inventory Management, SOP Adherence, Reagent Preparation, Data Reporting, PHI Protection, Microsoft Office Suite

Industry

Medical Equipment Manufacturing

Description

Autonomous Medical Devices Incorporated (AMDI), based in California, is a fast-growing company on a mission to transform point-of-care diagnostics. Our team of world-class engineers, scientists, clinicians, and manufacturing experts is pioneering breakthrough technologies in microfluidics, protein engineering, and cloud-connected data systems. We’re gearing up to launch our inaugural products from our ISO 13485-certified, 110,000-square-foot facility in Santa Ana, CA — and we're looking for passionate individuals to join us in shaping the future of healthcare. Location: This is an onsite position located at our Santa Ana, CA office. Candidates living within a 25 mile range preferred. Summary of Position The Clinical Operations Technician plays a key role in supporting clinical studies and the biocollection program. This hands-on role manages clinical samples and study supplies, maintains accurate records, and performs basic molecular biology testing (PCR/RT-PCR) in a BSL-2 lab environment. The ideal candidate is detail-oriented, collaborates with internal teams and external partners, and ensures strict compliance with regulatory standards, Good Clinical Practice, and patient data confidentiality. Essential Duties and Responsibilities Supports the external clinical studies, including working closely with R&D and Operations personnel and external clinical research organizations (CROs) on clinical studies. managing investigational devices inventory and clinical study supplies. organizing all applicable records for clinical studies and clinical samples. receiving clinical samples from clinical sites and transferring to the appropriate R&D collaborators and/or storage. proper storage of clinical samples following Clinical SOPs. Ensuring all activities are conducted in accordance with all applicable regulatory requirements, Good Clinical Practice (GCP) guidance and AMDI’s policies and procedures. Supports the internal biocollection program, including collecting and maintaining samples under the biocollection program (e.g., nasal swab samples, urine, saliva, etc.), including addressing R&D requests and managing the check-in/ check-out of stored specimens. prepares reagents for and executes PCR testing on clinical samples. provide written and/or oral updates to the team regarding data, progress, technical issues, etc. receiving clinical samples from the biocollection program and transferring to the appropriate R&D collaborators and/or storage. proper storage of clinical samples following Clinical SOPs. collecting and maintaining all the records for the biocollection program. coordinate and ensure inventory of critical lab reagents and supplies used for Clinical sample testing. Safeguards the clinical samples, clinical data and records, ensuring that the confidentiality, integrity and security of the clinical samples and clinical records are maintained, and PHI information is protected. Maintains all regulatory, legal, and financial disclosure documents per guidelines and regulations of the sponsor and IRB. Supports regulatory inspection activities. Works on other projects within QA & RA not related to clinical studies as assigned by management. Additional projects and/or duties as assigned. Qualifications Required for Position Minimum of an Associate degree in chemistry, biology or related field. Minimum of 6 months of hands-on experience with nucleic acid preparation, amplification and detection technologies using proper unidirectional molecular laboratory workflow. Experience with Good Laboratory Practices (GLP) and Good Documentation Practice (GDP) preferred. Cooperative and motivated team player with a positive attitude and solid work ethic. Sets specific goals and objectives to complete tasks on time in an organized manner. Effectively communicates in both written and oral presentations on data generated. Excellent attention to detail, record keeping and a passion for accuracy and precision. Ability to work in a fast-paced environment with deadline-driven workflows. Proficient in Microsoft Office Suite, specifically Word, Excel, PowerPoint, and Outlook. Demonstrates a strong ability to work collaboratively and shows a consistent willingness to support team members when needed. Ability to uphold strict protocols to preserve the confidentiality, integrity, and security of clinical samples and clinical records at all times. Work Environment Work requires some time in front of the computer. In-person position that requires working indoors in a BSL2 facility and testing laboratory environment. Requires the use of personal protective equipment to prevent exposure to biohazardous waste and chemicals. Some exposure to warehouse environment. Autonomous Medical Device Incorporated offers a comprehensive compensation and benefits package to eligible employees. The following is available for temporary employees: Free lunch to all employees when working at one of AMDI’s on-site locations. Casual dress code. Employee discounts on activities such as theme parks, movie theaters, hotels, rental cars, etc. Monthly company-wide socials. Salary Range The estimated base salary range for this position is $20 - $22 per hour. If the level of the role changes during the hiring process, the applicable base pay range may be updated accordingly. The actual base salary offered will be determined by several factors, including, but not limited to, the applicant's qualifications for the position, years of relevant experience, distinctive skills, and level of education attained. Autonomous Medical Devices Incorporated (AMDI) will not accept unsolicited resumes from any source other than directly from a candidate. An Agency must obtain advance written approval from AMDI’s internal Human Resources team to submit resumes only in conjunction with approved valid fully executed contracts. We are not currently entertaining Staffing agency assistance for this position. Our commitment to an inclusive workplace: We are an equal opportunity employer and encourage people from all backgrounds to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status, or any other protected characteristic under federal, state, or local law.

Responsibilities

This technician supports external clinical studies and the internal biocollection program by managing clinical samples, study supplies, and maintaining accurate records in compliance with GCP. Key duties include performing basic molecular biology testing like PCR/RT-PCR in a BSL-2 environment and ensuring proper storage and transfer of specimens.