Clinical Affairs Associate

Description

• This position is remote for candidates located outside of the Oklahoma City metro area. For candidates within the Oklahoma City metro area, the position will be hybrid.
  
  

Job Purpose

Aim (Why does the role exist?): To support clinical studies focused on the evaluation of diagnostics for fungal infections. This role provides the opportunity to build expertise in clinical research while contributing to advancements in medical mycology.

Goal (What does success in the role look like?): To coordinate and monitor the planning, execution, and reporting of clinical studies for IMMY’s fungal diagnostic tests, ensuring accurate data collection, regulatory compliance, and timely study completion.

Key Duties And Responsibilities

• Assist in planning, coordinating, and management of clinical research studies for fungal diagnostic tests.
• Draft, review, and maintain study documents (protocols, case report forms, informed consent forms, database forms, monitoring plans, etc.).
• Oversee data cleaning and chart abstraction.
• Schedule and coordinate meetings with site investigators, collaborators, and internal teams.
• Document and distribute meeting minutes and call notes.
• Coordinate IRB submissions track compliance.
• Manage specimen requests and logistics.
• Support site selection, initiation, monitoring, and documentation activities.
• Ensure compliance with study protocols, GCP, ICH, CLIA, and regulatory requirements.
• Assist with regulatory submissions, study reports, and study close-out activities.
• Prepare supporting materials for regulatory submissions (appendices, administrative sections).
• Contribute to cross-functional team meetings (BD, R&D, regulatory, marketing, sales) by providing clinical study updates.
  
  

Qualifications

Required Qualifications:

• Bachelor's degree in life sciences, microbiology, public health, or related field.
• 1-3 years of experience in clinical research (academic, hospital, or industry).
• Strong interest in clinical research and infectious diseases.
• Familiarity with GCP, ICH, CLIA, and regulatory requirements for clinical studies.
• Excellent organizational skills and ability to manage multiple projects.
• Strong written and verbal communication skills.
• Ability to work independently and collaboratively.
• Willingness to travel domestically up to 20%.
  
  

Desired Qualifications

• Master’s degree in public health, epidemiology, clinical research, or related field.
• Experience or coursework in infectious diseases, diagnostics, or medical mycology.
• Prior CRA monitoring experience (remote or on-site).
• Familiarity with FDA/IVDR requirements for invitro diagnostic (IVD) devices.
• Knowledge of clinical research management systems is a plus.
• Experience supporting medical affairs activities (publications, KOL engagement, advisory boards, cross-functional projects).
  
  

Equal Opportunity Employment: IMMY is committed to the principle of equal employment opportunity for all employees and applicants for employment and prohibits discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, and local laws. IMMY will not tolerate discrimination or harassment based on any of these characteristics. This policy applies to all terms and conditions of employment, including, but not limited to, recruiting, hiring, promotion, termination, leaves of absence, compensation, and training.

Background Check Policy: All offers of employment at IMMY are contingent upon clear, acceptable results of a thorough background check. IMMY performs all background checks in compliance with EEOC and FCRA regulations and all other applicable federal, state, and local laws.