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Clinical Research Operations Manager

2 months ago

Dallas, Texas, United States Baylor Scott & White Healthcare Full time
Clinical Research Operations Manager
  • Overview: This role entails the daily oversight of flow cytometry core operations and personnel.
The successful candidate will possess extensive knowledge and practical experience in flow cytometry sample handling, specimen evaluation, and cell sorting under BSL2+ conditions, coupled with exceptional leadership and communication abilities.

This position is vital to our project development initiatives, contributing scientific knowledge, experimental assistance, and innovative solutions to advance scientific endeavors.

The Clinical Research Operations Manager will work collaboratively with both internal and external research teams.

This role includes the daily management of clinical research personnel within the department.

Key Responsibilities:

  • Drafts and aids in the creation of proposals, grants, contracts, and budgets for the department.
  • Contributes to the formulation of new protocols and materials provided by study sponsors, offering insights to Principal Investigators (PIs) and management on clinical and research matters to assess financial and clinical viability.
  • Assists various PIs, under delegated authority, in executing clinical trials in accordance with federal, state, and institutional regulations.
  • Prepares initial project submissions, amendment notifications, Serious Adverse Event (SAE) reports, continuing review documents, and other reports for the Institutional Review Board (IRB).
  • Reviews submissions prepared by team members to ensure compliance with established standards.
  • Supervises case report form completion by staff for all studies and aids in coordinating audits by study sponsor monitors.
  • Monitors assigned Clinical Research budgets.
  • Trains, supervises, and evaluates Clinical Research personnel, fostering their growth through increased responsibilities and educational opportunities.
  • Coordinates project assignments for team members.
  • Maintains positive relationships with the public, patients, and staff, promoting the department's research initiatives.
  • Oversees communication with the IRB, Food and Drug Administration (FDA), and other relevant regulatory bodies.

Key Success Factors:

  • Preferred research certification or other relevant certifications.
  • Basic Life Support (BLS) certification as per departmental requirements.
  • Demonstrated written and verbal communication skills.
  • Proficient in computer applications, including Microsoft Office, Excel, and PowerPoint.
  • Ability to manage multiple projects effectively to meet deadlines.
  • Capability to establish and maintain productive working relationships.
  • Outstanding leadership skills.

Benefits: Our comprehensive benefits package includes:

  • Immediate eligibility for health and welfare benefits
  • 401(k) savings plan with a dollar-for-dollar match up to 5%
  • Tuition Reimbursement
  • PTO accrual beginning Day 1

Qualifications:

  • Education: Bachelor's degree or 4 years of relevant work experience beyond the minimum qualifications.
  • Experience: Minimum of 2 years of experience; a bachelor's degree in biology or a closely related field is required.

At least 5 years of hands-on experience with flow cytometry (minimum of 5 colors), including design, acquisition, and analysis. Experience with multi-parameter sorting, preferably on BD flow cytometers (AriaII and Influx), is advantageous. A thorough understanding of commercial flow cytometry software, including Flow Jo and BD FACS Diva, is essential. Knowledge in multi-parameter flow cytometry analysis of immune cells, particularly with large antibody panels, is preferred. A strong background in immunology and/or microbiology is also required.