Full-timework in San Diego (Hybrid)
Salary commensurate with experience
Health and Dental Plans plus paid vacation
Apply now by submitting a cover letter and resume with the names and contact information of three references to email@example.com. Please clearly indicate in your application how you meet the requirements for this role, and why you think you would be the best candidate for the role.
Entos Pharmaceuticals Overview
Entos Pharmaceuticals Inc. is a clinical-stage genetic medicines company headquartered in Edmonton, Alberta, Canada, with offices in London, UK, and office and lab facilities in San Diego, California, USA. Entos’ proprietary Fusogenix PLV drug delivery system is formulated with FAST proteins to enable the delivery of nucleic acid payloads, such as DNA and RNA, directly into target cells. This technology is applicable to a wide range of genetic medicines. Fusogenix PLVs have demonstrated, in multiple studies, to be well tolerated at high systemic doses, redosable, and able to target multiple tissues in the body. Please visit www.entospharma.com for more information.
The successful candidate will be responsible for the administrative and operational support of internal and external Entos research projects including the development of genetic delivery, chemistry, and innovation. Reporting to the CSO, this position will play a critical role in ensuring the project meets desired outcomes efficiently and within desired timeframes by supporting financial, operational, and administrative processes. The Research Coordinator will have an in-depth knowledge of systems and processes governing clinical research and will be able to adapt quickly to change.
Duties & Responsibilities
Financial Administration of Research Funds
· Advise the CSO with respect to expenditures and the project’s overall financial position, provide regular projections, monitor monthly spending, and ensure budget line items are on target.
· Work with team members on as-needed on financial administration matters.
· Ensure financial transactions are compliant with sponsor policy and procedure; maintain financial records accordingly.
Coordination of Resources and Materials
· Approve, process, and track project expenses and purchase project supplies.
· Liaise with internal contacts and external agencies to ensure the distribution of supplies and study materials.
· Ensure purchases are administered through the appropriate procedure.
Compliance & Reporting
· Design and prepare project materials including consent forms, questionnaires, data collection forms, ethics applications, agreements, etc.
· Assist with regulatory applications and operational approvals to stakeholders and governing bodies such as NIH, Health Canada, Alberta Health Services, etc.
· Ensure study and project data and correctly stored and uploaded according to appropriate privacy legislation.
· Support Quality Assurance activities by identifying data queries, gaps, errors, missing data, and direct staff on corrections of data.
· Assist with data analysis and perform regular monitoring analyses to track project progress and report on progress to study leads.
· Support the distribution, collection, and review of regulatory documentation.
· Review Informed Consent and regulatory documents to ensure adherence to ICH-GCP guidelines as well as project and sponsor-specific requirements.
· Develop and maintain correspondence with regulatory agencies, sponsor(s), external partners, and clinical sites to assist in the ongoing monitoring and evaluation of the project.
· Liaise with Quality Management, ensuring project operations are compliant.
Personnel Administration Support
· Act as a resource for research staff on day-to-day questions.
· Serves as an administrative point-of-contact for departmental, faculty, and Human Resource Services staff on project-related administrative matters.
· Supports the CSO and other research leads in human resources matters.
· Identifies when to escalate inquiries to the appropriate administrator or the CSO or refer questions to the appropriate contact person.
Research Review & Grant Writing
· Ensure familiarity with the uniform requirements for publication in scientific journals.
· Provide guidance and advisory expertise to researchers and practitioners on funding opportunities and grant applications.
· Creates and/or reviews materials and communications prepared by project team members and provides appropriate feedback when necessary.
· Other duties as assigned.
Qualifications (list the minimum education and on-the-job experience required for this position)
· Minimum of a Bachelor’s degree in health sciences, social sciences, or a related area. Equivalent combinations of education and experience will be considered.
· 4-7 years experience in health care or social sciences, with preference given to those with experience in research support or clinical trials
· Training and experience in project management
· Recent coursework or work experience in quantitative and qualitative research methods.
· Intermediate to advanced knowledge of computer applications (MS Word, PowerPoint, Excel, email, Internet, Google Applications, etc.) is essential.
· Strong interpersonal, communication, and facilitation skills.
· Able to understand new concepts, tasks, and instructions quickly and effectively.
· Highly developed organizational and time management skills including demonstrated ability to manage multiple deadlines and projects
· Strong mathematical and analytical skills.
· PMP /CAMP certification
· High volume device and/or drug development and project management within the medical device/pharmaceutical industry, or a reasonable combination of the two
· Strong familiarity with the integration of requirements and deliverables associated with Design Controls (21CFR820.30) into the product development process
· Experience with short-release cycles
· Experience managing ambiguity and providing clarity for teams
· Experience working in a highly government-regulated environment (FDA, MDR).
· Experience leading a cross-functional project team through regulatory submission and product commercialization
· Demonstrated learning agility in new subject matter
· Demonstrated application of product development and project management best practices on recent programs
This position is only for applicants who have a valid permit to work in the United States This position is flexible, and the successful candidate may be given the option to work remotely partly. This will be a salaried position and compensation will be determined based on the skill set and experience of the selected candidate. Entos Pharmaceuticals offers health and dental plan and paid vacation.
We are an equal opportunity employer and consider all qualified applicants equally without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.