Clinical Research Coordinator - Hybrid - Amy Cell Talent

Passionate about advancing clinical research? Join ONL Therapeutics and play a key role in pioneering treatments that protect and restore vision!

About Us

ONL Therapeutics is a clinical-stage biopharmaceutical company committed to helping patients see the future. Our mission is to develop innovative therapeutics to protect and improve the vision of patients with a range of retinal diseases and conditions. Headquartered in Ann Arbor, Michigan, the company is looking for dynamic self-starters to join the company. The company’s lead therapeutic candidate, ONL1204, is a first-in-class small peptide with a unique and differentiated mechanism of action. By inhibiting the Fas receptor, ONL1204 effectively blocks the activation of the Fas pathway and the related immune signaling which results in the death of key retinal cells and loss of vision. ONL’s lead compound ONL1204 Ophthalmic Solution is being studied across the following indications:

• A Phase 2 clinical study in patients with macula-off, rhegmatogenous retinal detachment. This US-based study is now complete with final CSR and closeout activities underway. 
• A Phase 1b clinical study in patients with geographic atrophy (GA) associated with age-related macular degeneration (AMD). This study conducted in Australia and New Zealand is now complete with final CSR and closeout activities underway.
• A Phase 1b clinical study in patients with open-angle glaucoma. This study conducted in Australia and New Zealand is now complete with final CSR and closeout underway.
• ONL is now preparing for a global Phase 2 study in GA to be launched in in 2024.

To learn more, please visit: https://www.onltherapeutics.com/

About the Role

The Clinical Research Administrative Coordinator (CRAC) is responsible for performing a variety of activities essential to the day-to-day conduct of clinical trials and Sponsor management of Clinical Research Organizations (CROs). This position reports to the Vice President of Clinical Operations and also supports the VP of Clinical Affairs. This is a full-time, on-site position located at the company’s Ann Arbor headquarters office. Occasional after hours work may be required due to global time zones.

Key Responsibilities:

• Assists with the review of clinical study-related documents and materials; for example, reviewing meeting minutes, agenda preparation, reviewing and editing key documents 
• Provides administrative management of key activities for the ONL clinical team including meeting coordination, minuting and coordinating follow-ups
• Helps organize, draft and implement communications to multiple stakeholders, including study sites, key opinion leaders, vendors and other collaborators in a professional manner
• Organizes study files, including but not limited to, regulatory submissions, study specific trial master documents and other materials
• Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, and applies that knowledge to document reviews
• Collaborates with external vendors and partners on following activities:
  • Help with planning and preparations for key clinical trial related events such as Investigator Meetings, Advisory Board meetings and others
  • Review of CRO project-related documents
  • Coordinate and participate as needed in various stakeholder meetings
  • Liaise with vendors  
  • Track study progress, invoices, and other project management tasks
  • Escalation of issues to Director of Clinical Operations and others, as appropriate

About You

• Bachelor’s degree in a scientific, health related, or business administration program, preferred. Experience in a clinical research environment is a plus. 
• Knowledge of or interest in learning more about medical terminology, clinical medicine, clinical trials and associated regulatory considerations. 
• Detail-oriented and meticulous in all aspects of work. 
• Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative.
• Professional demeanor and strong communication skills with the public as well as collaborators and physicians/researchers.
• Ability to work well independently as well as in team environment.  
• Possess the ability to work well under pressure, multi-task, be flexible, and manage deadlines.
• Proficient in Microsoft Office Word, Powerpoint and Excel. 

Why work with us?

• Compensation includes salary, bonuses and stock options.
• Benefits include health, vision and dental insurance plans, 401(k), holidays and vacation. 
• Hybrid schedule with the flexibility to WFH on Mondays and Fridays.

EEO Statement 

ONL is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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