Clinical Project Assistant, Clinical Affairs

2 weeks ago

Aliso Viejo, United States Spyglass Pharma Full time
Job DescriptionJob DescriptionSalary: $28-32 Hourly

About SpyGlass Pharma:


At SpyGlass Pharma, we are actively engaged in projects addressing unmet needs in glaucoma and cataract surgery/intraocular lens replacement, striving for paradigm shifts in global eye care.

 

Our team comprises professionals with diverse expertise in ophthalmic devices and drug delivery. Our accomplished scientists and engineers work alongside a seasoned leadership team with extensive experience in ophthalmology, IOL development, and commercial success. Led by a proven team with expertise in science, R&D, communications, and operations, SpyGlass Pharma™ takes ideas from inception through commercialization.


Our commitment to actively improving patients’ quality of life drives the company to innovate and succeed.

Learn more at www.spyglasspharma.com 


Summary:


We are seeking a Clinical Project Assistant (CPA) of Clinical Affairs to join our team at SpyGlass Pharma. The CPA is responsible for executing the tasks on the clinical team throughout the clinical trial. This position has the responsibility for supporting the clinical team in the day-to-day operations in support of the clinical trials. This includes responsibility for the clinical team’s creation of relevant documents and outputs including feasibility questionnaires, regulatory documents, enrollment reports, data listings, and patient summaries.  The CPA will read the investigator brochures, study protocol synopsis, clinical study protocols. This position executes and implements various tasks to assist in the achievement of all activities related to the Clinical development program. The position may interact with multiple levels in the clinical organization, participating in discussions with clinical management and providing clinical updates.


Essential Duties & Responsibilities:


  • Support the Clinical Affairs team to execute tasks throughout the clinical trials.
  • Work with clinical team to execute tasks, programs, and protocols.
  • Provide support to the clinical teams.
  • Learn about clinical issues and help to resolve them.
  • Attend FDA, Regulatory Agency, IRB/IEC meetings as needed.
  • Track and file regulatory documents, files, dossiers as needed.
  • Participate in regulatory document collection and follow-up with team members, ensuring that all documents and tasks are in accordance with predetermined timelines.
  • Work in a dynamic, matrixed environment by collaborating closely with cross-functional teams, including R&D, Regulatory Affairs, Quality Assurance, and project management teams, while following GCP and industry best practices.
  • Interact with members of the clinical team, vendors, and consultants.
  • Learn about clinical trends, changes, and requirements in the pharmaceutical industry.

 

Qualifications Required For Position:


  • Bachelor's degree preferred.
  • Minimal or no years of experience in clinical affairs or similar field
  • An awareness of clinical trials.
  • Willingness to learn leadership, communication, and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external partners.
  • Willingness to learn about clinical strategy development, investigational product supply, regulatory compliance, and clinical activities for clinical trials of all phases.
  • Ability to work in a fast-paced, dynamic environment and manage multiple projects simultaneously while maintaining attention to detail and quality.


SpyGlass Pharma is an Equal Opportunity Employer and participates in E-Verify. SpyGlass Pharma takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.

 

SpyGlass Pharma is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to JOBS@SPYGLASSPHARMA.COM and let us know the nature of your request and your contact information.

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