Clinical Microbiology Study Manager (Santa Barbara, CA)

Affinity Biosensors - Los Angeles, CA

Full-time

Clinical Microbiology Study Manager

Affinity Biosensors (Santa Barbara, CA) has opened a full-time, high-impact position to design and monitor studies that validate the performance of its LifeScale rapid antibiotic susceptibility system.

Candidates should have extensive experience in microbiology R&D, study construction, and USFDA 510(k) clinical trials. Previous experience in microbiology laboratory research or study development, and/or commercial development of in-vitro diagnostic equipment pertaining to antibiotic susceptibility testing, is highly valued.

M.S. or Ph.D. degree in Microbiology or related field is required.

Duties include:

· Monitor ongoing clinical trials, including coordination with study monitor, communication with study sites, monitoring of study data and consumables

· Design protocols and monitor analytical studies in support of clinical trials

· Draft 510(k) pre-submission communications to the FDA for additional clinical trials

· Train laboratory staff on study protocols, in-house and at study sites

· Interact with engineering and quality systems groups

· Some travel required

Required Skills:

· Detailed knowledge of microbiology lab function and clinical microbiology workflow

· Superior oral and written communication skills and leadership abilities

· Ability to thrive in a multi-tasking, multi-disciplinary environment

· Critical thinking skills for advanced problem-solving

Affinity Biosensors offers competitive salaries and benefits, and opportunities for equity.

Job Type: Full-time

Experience:

  • relevant: 5 years (Required)
  • clinical research study design and management: 2 years (Preferred)

Education:

  • Master's (Required)

Application Question:

  • How many years experience with IVD product FDA Clinical Trials?