Clinical Trials Operations Specialist

About the role

The Clinical Trial Operations Specialist is responsible for connecting science and operations to bring clinical studies to life through the execution of Phase I clinical trials. This position will be primarily responsible for executing efforts to operationalize regenerative, gene, and cellular therapy clinical trials while building and maintaining strong and impactful relationships and working cross-functionally and collaboratively support trial operations.

Responsibilities

• Independently coordinates the day-to-day operations and compliance of multiple highly complex Phase 1 clinical trials, across internal and external teams, from start-up to close-out.
• Develops a project plan for the study protocols to ensure the projected timelines, milestones, and budgets are met; provides senior leadership with metrics and updates as required.
• Supports core team meetings for assigned studies ensuring goals and deliverables are clearly defined, and issues, decisions, risks, and actions are appropriately tracked.
• Acts as the primary resource and liaison between the site and internal/external stakeholders, to ensure timely study launch, administrative study maintenance, and closeout in accordance with local, state, and federal regulations, as well as contractual obligations.
• Works closely with leadership, internal constituents, ancillary committees, and external Sponsors to resolve barriers to trial activation and improve protocol activation timelines.
• Affords assistance in the development of protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs), and Case Report Forms (CRFs).
• Consults with investigators in developing submissions and responding to questions and requests for revisions from internal and external committees and boards (e.g., IRB).

  Requirements

  • A bachelor’s degree in business, business administration, nursing, finance, accounting, education, social sciences, physical/biological sciences, engineering, healthcare administration, public administration, communications, information systems, or a directly related field from an accredited institution.
  • At least 2 years of professional level experience in clinical trial operations.
  • Minimum qualifications at the time of hire.
  • Master's degree in health-related discipline preferred.
  • Registered Nurse (RN) licensure or prior professional clinical experience preferred.
  • Experience with coordinating operations of clinical trials in the cellular and/or gene therapy space preferred.
  • Certified as a Clinical Research Professional (CCRP or equivalent) preferred.
  • Experience submitting Investigational New Drug (IND) applications preferred.
  • Certified Associate in Project Management (CAPM), Project Management Professional (PMP) Certification, and/or project management experience in an academic environment preferred.
  • Professional clinical research experience in an academic medical center preferred.

  Qualifications

  • Strong critical thinking and problem-solving skills required.
  • Exceptional communication and interpersonal skills, both oral and written.
  • Excellent multi-tasking and organizational skills, as well as the ability to make complex decisions in a fast-paced environment.
  • Ability to learn quickly and understand new technical concepts and processes.
  • Flexible and able to adapt to program growth and evolving responsibilities.
  • Self-motivated and able to work in a team environment.
  • Able to work well under pressure, especially when assisting involved stakeholders.
  • Proficiency in Microsoft Suite (especially Excel, PowerPoint, Word, and Project).
  • A strong working knowledge of Good Clinical Practices (GCP), U.S. Food and Drug Administration (FDA) rules and regulations in relation to clinical trials, National Institutes of Health (NIH) guidelines, International Council for Harmonization (ICH) guidelines, Health Insurance Portability and Accountability Act (HIPAA) regulations in relation to clinical trials, and other universally accepted practices and procedures within clinician trial management.

  Benefits

  The University of Colorado offers an excellent benefits package including:

  • Multiple plan options for Medical and Dental.
  • Disability, Life, Vision insurance.
  • Retirement 401(a) Plan with employer contribution of 10% of your gross pay.
  • Paid Time Off: Accruals over the year.
  • Holiday Days: 15/year.
  • Tuition Benefit: Employees have access to this benefit on all CU campuses.
  • ECO Pass: Reduced rate RTD Bus and light rail service.

  How to Apply

  To apply, please submit the following document(s): A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position. A curriculum vitae / Resume. Three professional references, including name, address, phone number (mobile number if appropriate), and email address.

  Contact Information

  Questions should be directed to: Vanessa McWhirt, HR Generalist. vanessa.mcwhirt@cuanschutz.edu