Clinical Affairs Specialist

Autonomous Medical Devices Incorporated (AMDI) is an early-stage, California company focused on developing and manufacturing Autolabs and their associated test discs for human clinical diagnostics. Each of AMDI’s Autolabs are small, portable point-of-care diagnostics devices using breakthrough microfluidics, hardware, and data/cloud connectivity to deliver secure lab quality results in <15 minutes. AMDI has built a world class, multi-disciplinary team of engineers, scientists, clinicians, and database experts and will launch its first Research Use Only (RUO) products in 2023 from its ISO 13485 certified 110,000 square foot facility in Santa Ana, CA.

Summary of Position

We are seeking a highly motivated and enthusiastic individual to join our dynamic biotech industry team.  The primary responsibilities of the Clinical Affairs Specialist (CAS) include supporting external clinical studies and managing the internal biocollection program.   To support the external clinical studies, the CAS will work closely with R&D and Operations personnel and external clinical research organizations (CROs), manage investigational devices and clinical study supplies, organize records for clinical studies and clinical samples, etc. in accordance with all applicable regulatory requirements, Good Clinical Practice (GCP) guidance and AMDI’s policies and procedures. The CAS may participate in the clinical study site initiation and ongoing monitoring of the clinical studies.  To manage the internal biocollection program, the CAS is responsible for drafting or updating biocollection protocols, maintaining IRB approval of the biocollection program, collecting and managing samples under the biocollection program (e.g., nasal swab samples, urine, saliva, etc.), collecting and maintaining all the records for the biocollection program.  The CAS is responsible for protecting PHI information, safeguarding the clinical samples, clinical data and records, ensuring that the confidentiality, integrity and security of the clinical samples and clinical records are maintained. 

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 and clinical study supplies
  • participating in the clinical study site initiation
  • performing on-site and remote/virtual monitoring activities including interim monitoring visits or closeout visits
  • organizing all applicable records for clinical studies and clinical samples, 
  • verifying source data/documents and other clinical study records are accurate, complete, and maintained
  • monitoring the regulatory status of clinical investigators as well as study/site/vendor issues for GCP risks and take action when necessary
  • monitoring IRB activities, including additional site submissions, amendments/changes in research submissions, facilitating submission of annual continuing review reports, monitoring and notifying of document expiration dates, and process fees through accounts payable.
  • ensuring all activities are conducted in accordance with all applicable regulatory requirements, Good Clinical Practice (GCP) guidance and AMDI’s policies and procedures.  
• Manages the internal biocollection program, including 
  • drafting or updating biocollection protocols
  • maintaining IRB approval of the biocollection program
  • collecting and managing 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
  • collecting and maintaining all the records for the biocollection program 
• 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

Qualifications Required for Position

• Bachelor’s degree in life sciences or health-related discipline, or RN required with a minimum of 4 years of clinical study experience, or advanced degree with a minimum of 2 years of clinical study experience, in a regulated environment (CLIA or FDA regulations) 
• Experience with conducting clinical studies within the medical device, pharmaceutical, or biotechnology industry 
• In-depth knowledge of FDA regulations and ICH Guidelines on clinical studies 
• Excellent attention to detail and strong organizational skills 
• Ability to work closely with both internal and external personnel to increase the level of compliance and cooperation while creating opportunities to improve operations and effective implementation to reduce errors 
• Excellent verbal and written communications, problem-solving, analytical thinking skills 
• Must be self-motivated to work independently on multiple tasks. Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency 
• Ability to carry out monitoring of investigator sites and clinical research vendors. Requires an in-depth knowledge of monitoring principles, techniques, and communication skills to clearly and efficiently convey findings and report deficiencies 
• Ability to identify and escalate problems and follow-through with corrective actions 
• Consistently exhibits a professional demeanor in the workplace and works to maintain positive relationships 
• Proficient in Microsoft Office Suite, specifically Word, Excel, PowerPoint, and Outlook

Desired skills and traits

• Experience with clinical studies of In Vitro Diagnostic (IVD) medical devices 
• Experience with clinical trial management software (CTMS) 
• Advanced understanding of medical device risks/hazards and associated patient harms in the point-of-care settings 
• Experience writing and presenting complex medical or technical documentation in a manner that is easily understood by individuals with varying levels of technical and medical expertise 
• Ability to work well in a dynamic, fast paced work environment 
• Project management experience/skills

Work Environment

• Work requires to be indoors with some time in front of the computer, other times working in a laboratory environment. Frequently required to wear personal protective gear to prevent exposure to hazardous materials typically found in the lab environment. 
• May require up to 20% travel to clinical study sites (domestic)

Autonomous Medical Device Incorporated offers a comprehensive compensation and benefits package to eligible employees including:

Company provided lunch to all employees when working at one of AMDI’s on-site locations.

- 401(k) match

- Health insurance, 100% paid for by employer including: Medical, Dental, Vision & Life Insurance

- Competitive vacation, sick days & paid holidays

- Tuition reimbursement

- Casual dress code

- Employee discounts on activities such as theme parks, movie theaters, hotels, rental cars, etc.

- Monthly company-wide social

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.

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.