Senior In-House Clinical Research Associate

Location: Deerfield, IL, USA

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Workplace Type: Remote

The Senior In-house Clinical Research Associate (Sr IHCRA) works closely with the Clinical Trial Manager (CTM) and Clinical Research Associates (CRAs) by providing centralized support to regional team members assisting with the preparation, organization and follow-up of investigator and study site selection, site communication, and clinical monitoring activities at a local and international level.

Responsibilities:

  • Act as a mentor / Subject Matter Expert (SME) for other IHCRAs
  • Responsible for training/onboarding new IHCRAs
  • Assist with monitoring of site performance and implementation of action plans for sites not meeting expectations , in conjunction with the CRA
  • Assist CRAs with preparation for site visits (through running reports, query and action item resolution, regulatory document collection)
  • Serves as the primary CRA back-up
  • Provides general support to the CTM and CRAs to manage investigational sites and ensure protocol and regulatory compliance
  • Contributes to the development of protocol-specific manuals, plans, and documents, as needed
  • Assists with the development of training content (monitoring visit training materials, monitoring visit reports, etc.)
  • Supports site identification and qualification through feasibility tasks
  • Assists with Investigator Meeting planning and attendance
  • Assists with resolution of investigational site data queries
  • Assists and supports CRAs with Action Item resolution
  • Supports CRAs with Investigation Product reconciliation
  • Tracks patient enrolment and assists with recruitment efforts by maintaining regular site contacts
  • Assists CRAs with document collection and TMF (Trial Master File) uploads
  • Can co-monitor and/or conduct remote SDV on assigned studies as needed and approved by management
  • Assists the CTM with Action Item and Protocol Deviation review and follow-up, and quality management activities
  • Leads the development of study newsletters
  • Maintains FAQs for assigned studies
  • Documents site and sponsor contacts and study interactions in a timely and professional manner
  • Performs other duties as assigned per study and/or Advanced Clinical needs

Qualifications:

  • Minimum requirement of a Bachelor’s degree in biological sciences, healthcare, pharmacy, or nursing, or equivalent combination of education and experience.
  • 2 years experience as an IHCRA
  • 2+ years of clinical research experience in a clinical research site, CRO, or healthcare or industry setting. Prefer scientific discipline and multiple therapeutic experiences.

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation.  Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.

EEO Employer Verbiage:

At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.

Equal Employment Opportunity

It is Advanced Clinical’s practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law.

This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.