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We follow the science that will lead us to the best possible outcomes for patients.

Mission

We are a mutation-agnostic in vivo gene editing company striving to cure liver disorders with high unmet needs by harnessing new advancements in genetic medicine. Our in vivo insertion methods knock in healthy copies of disease-causing genes, offering long-term, stable expression of those genes in patients.

Culture

Our science is at the leading edge, and so are we. Our team of experts is here to transform lives and bring potentially curative treatments to patients in need. Great work takes a deep level of collaboration at all levels, and we strive every day to foster an environment that inspires innovation, execution and an unrelenting commitment to patients.

We are built on the world-class translational engine at the University of Pennsylvania’s Gene Therapy Program (UPenn GTP). The work executed by this group of world‑renowned gene therapy experts on our pipeline provides a substantial developmental head start – meaning treatments in the hands of patients as quickly as possible.

Work With Us

Interested in joining our team of genetic medicine experts?

Please email careers@iecure.com to learn more, and browse our current job openings below.

No current openings.

Position Summary:

The Senior Clinical Research Associate (CRA) will report directly to the Senior Director Clinical Operations. This position has the responsibility of supporting the company’s clinical operations function in close collaboration with research, development, and other functions. This includes working directly with the study team, vendors, and clinical study sites to ensure that clinical trials are conducted in a manner compliant with SOPs, ICH/GCP/CFR regulatory guidelines, as well as in line with company goals, timelines, and budgets.

This individual will be accountable for executing on the operational plan for clinical studies and leading site training, patient finding/recruitment, data collection and source data verification activities at the site level according to program timelines and quality targets. The Senior Clinical Research Associate will be a seasoned professional with a background in life sciences and end-to-end clinical operations experience from working within the biotech or pharmaceutical industry. Experience supporting clinical trials for rare disease indications is preferred.

Characteristics sought for a good cultural fit to the company include the ability to work collaboratively, strong organizational skills, excellent planning and communication and interpersonal skills, ability to think strategically and act independently, a “hands on” approach in the implementation of an agreed-upon plan, nimble problem-solving skills, an innate sense of urgency, creative thinking about what is possible in execution, and general positivity.

Responsibilities

  • All aspects of study site monitoring and management from site start-up activities to close-out of clinical sites, maintenance of study files, including routine monitoring (including, Confirmation/Follow-up Letters, trip report completion and follow-up) and other duties, as assigned
  • Establish, grow, and maintain strong relationships with key study site staff (e.g., PIs, Sub-Is, SCs, Genetic Counselors, Dietitians, Pharmacy Directors)
  • Recruitment of potential investigators, preparation of IRB/EC submissions, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned
  • Independently perform CRF review; query generation and resolution against established data review guidelines per SOPs or data management systems as assigned by supervisor
  • Develop patient recruitment planning and strategy at the site levels
  • Proactively identify potential study issues/risks and recommend solutions
  • Maintain systems (eTMF, CTMS, EDC, etc.) that track progress throughout the duration of the program
  • Manage all site activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
  • Ensure appropriate clinical trial supplies are planned and ordered in time for all assigned sites
  • Hold clinical sites accountable to study timelines for start-up, patient recruitment strategies, enrollment, and quality data deliverables

Qualifications

  • A BA/BS degree required; advanced degree with scientific or health-care training preferred
  • Minimum of at least 3-4 years of Onsite Clinical Monitoring experience. At least 1-year additional experience in related field
  • Advanced site monitoring; and study site management skills
  • Thorough knowledge of monitoring procedures and strong understanding of the drug accountability process
  • Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
  • Strong knowledge of rare disease clinical research highly desired
  • Knowledge and experience in gene therapy and gene editing, preferred
  • Experience with pediatric, in-patient / hospital-based studies, highly desired
  • Experience monitoring global clinical trials for a product through all clinical phases of clinical development
  • Demonstrated career success as a seasoned CRA, effective organizational skills, excellent verbal and written communication skills and high attention to detail
  • Excellent working knowledge of FDA & ICH/GCP/CFR regulations and guidelines
  • Ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple individuals
  • A professional who inspires trust and confidence in others. A resourceful, energetic self-starter who can shift between collaboration and execution
  • Possess unquestionable integrity with the highest ethical standards
  • Willingness and ability to participate in domestic and international travel, as required, up to 20%. Valid driver’s license and current passport

Department

Operations

Updated

June 2024

Location

Fulltime, Onsite, East Coast

EEO

iECURE is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.